Greene Et Al 2016

Cochrane Database of Systematic Reviews
Oral stimulation for promoting oral feeding in preterm infants

(Review)
Greene Z, O’Donnell CPF, Walshe M
Greene Z, O’Donnell CPF, Walshe M.

Oral stimulation for promoting oral feeding in preterm infants.
Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: CD009720.
DOI: 10.1002/14651858.CD009720.pub2.
www.cochranelibrary.com
Oral stimulation for promoting oral feeding in preterm infants (Review)

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . 4
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figure 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Figure 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . 20
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Analysis 1.1. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care, Outcome 1 Days to full
oral feeding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Analysis 1.2. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care, Outcome 2 Weight
gain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Analysis 1.3. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care, Outcome 3 Total
hospital stay (days). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Analysis 1.4. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care, Outcome 4 Duration
(days) of parenteral nutrition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Analysis 1.5. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care, Outcome 5 Exclusive
direct breast feeding at discharge. . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Analysis 1.6. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care, Outcome 6 Any direct
breast feeding at discharge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Analysis 2.1. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 1 Time (days) to
achieve exclusive oral feeding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Analysis 2.2. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 2 Total hospital stay
(days). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Analysis 2.3. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 3 Duration (days) of
parenteral nutrition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Analysis 2.4. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 4 Exclusive direct
breast feeding at discharge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 74
Oral stimulation for promoting oral feeding in preterm infants (Review) i

[Intervention Review]
Oral stimulation for promoting oral feeding in preterm infants
Zelda Greene1 , Colm PF O’Donnell2 , Margaret Walshe3

1 Speech and
Language Therapy Department, Our Lady’s Children’s Hospital, Dublin, Ireland. 2 Department of Neonatology, National
Maternity Hospital, Dublin 2, Ireland. 3 Clinical Speech and Language Studies, Trinity College Dublin, Dublin, Ireland
Contact address: Zelda Greene, Speech and Language Therapy Department, Our Lady’s Children’s Hospital, Crumlin, Dublin, Ireland.
zeldagreene@gmail.com.
Editorial group: Cochrane Neonatal Group.

Publication status and date: Edited (no change to conclusions), published in Issue 2, 2017.
Citation: Greene Z, O’Donnell CPF, Walshe M. Oral stimulation for promoting oral feeding in preterm infants. Cochrane Database
of Systematic Reviews 2016, Issue 9. Art. No.: CD009720. DOI: 10.1002/14651858.CD009720.pub2.
ABSTRACT
Background
Preterm infants (< 37 weeks’ postmenstrual age) are often delayed in attaining oral feeding. Normal oral feeding is suggested as an
important outcome for the timing of discharge from the hospital and can be an early indicator of neuromotor integrity and developmental
outcomes. A range of oral stimulation interventions may help infants to develop sucking and oromotor co-ordination, promoting
earlier oral feeding and earlier hospital discharge.
Objectives
To determine the effectiveness of oral stimulation interventions for attainment of oral feeding in preterm infants born before 37 weeks’
postmenstrual age (PMA).
To conduct subgroup analyses for the following prespecified subgroups.

• Extremely preterm infants born at < 28 weeks’ PMA.
• Very preterm infants born from 28 to < 32 weeks’ PMA.

• Infants breast-fed exclusively.
• Infants bottle-fed exclusively.

• Infants who were both breast-fed and bottle-fed.
Search methods
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled
Trials (CENTRAL), MEDLINE via PubMed (1966 to 25 February 2016), Embase (1980 to 25 February 2016) and the Cumulative
Index to Nursing and Allied Health Literature (CINAHL; 1982 to 25 February 2016). We searched clinical trials databases, conference
proceedings and the reference lists of retrieved articles.
Selection criteria
Randomised and quasi-randomised controlled trials comparing a defined oral stimulation intervention with no intervention, standard
care, sham treatment or non-oral intervention in preterm infants and reporting at least one of the specified outcomes.
Oral stimulation for promoting oral feeding in preterm infants (Review) 1
Data collection and analysis
One review author searched the databases and identified studies for screening. Two review authors screened the abstracts of these studies
and full-text copies when needed to identify trials for inclusion in the review. All review authors independently extracted the data and
analysed each study for risk of bias across the five domains of bias. All review authors discussed and analysed the data and used the
GRADE system to rate the quality of the evidence. Review authors divided studies into two groups for comparison: intervention versus
standard care and intervention versus other non-oral or sham intervention. We performed meta-analysis using a fixed-effect model.
Main results
This review included 19 randomised trials with a total of 823 participants. Almost all included trials had several methodological
weaknesses. Meta-analysis showed that oral stimulation reduced the time to transition to oral feeding compared with standard care
(mean difference (MD) -4.81, 95% confidence interval (CI) -5.56 to -4.06 days) and compared with another non-oral intervention
(MD -9.01, 95% CI -10.30 to -7.71 days), as well as the duration of initial hospitalisation compared with standard care (MD -5.26,
95% CI -7.34 to -3.19 days) and compared with another non-oral intervention (MD -9.01, 95% CI -10.30 to -7.71 days).
Investigators reported shorter duration of parenteral nutrition for infants compared with standard care (MD -5.30, 95% CI -9.73 to -
0.87 days) and compared with another non-oral intervention (MD -8.70, 95% CI -15.46 to -1.94 days). They could identify no effect
on breast-feeding outcomes nor on weight gain.
Authors’ conclusions
Although the included studies suggest that oral stimulation shortens hospital stay, days to exclusive oral feeding and duration of
parenteral nutrition, one must interpret results of these studies with caution, as risk of bias and poor methodological quality are high
overall. Well-designed trials of oral stimulation interventions for preterm infants are warranted. Such trials should use reliable methods
of randomisation while concealing treatment allocation, blinding caregivers to treatment when possible and paying particular attention
to blinding of outcome assessors.
PLAIN LANGUAGE SUMMARY

Effects of oral stimulation for oral feeding in preterm infants
Review questions
Do oral stimulation interventions that involve finger stimulation protocols in preterm infants born before 37 weeks’ gestation:
• reduce time taken to achieve exclusive oral feeding and time spent in hospital?
• result in exclusive oral feeding, exclusive breast feeding or any direct breast feeding?
• increase sucking strength?
• increase rate of growth and improve development?
Background
Many preterm infants have delayed establishment of oral (suck) feeding and are fed at first with feeding tubes or with intravenous
(parenteral) nutrition. Development of oral feeding skills needs careful co-ordination of sucking, swallowing and breathing. In preterm
infants, the development of oral feeding can be challenging because of long hospitalisations, breathing difficulties and other medical
conditions associated with preterm birth. Unpleasant procedures such as ventilation or frequent suctioning of secretions from the
mouth or nose can negatively impact feeding skills. International guidelines for the transition from tube feeding to oral feeding vary
widely. Healthcare providers use a range of interventions to improve sucking and feeding skills in preterm infants, and studies report
faster transition time from tube feeds to oral feeds, reduced length of stay in hospital and improvement in infants’ sucking skills. No
Cochrane review has assessed the intervention involving finger stimulation of the mouth before and during feeds.
Study characteristics
This review included randomised controlled trials (RCTs) that explored oral stimulation by finger stimulation only in preterm infants.
Review authors identified studies to be included by searching electronic databases, clinical trials registers, peer-reviewed journals and
published conference proceedings.
Key results
We included 19 studies of poor quality with small numbers of participants. Study findings suggest that oral stimulation interventions can
shorten the transition to oral feeding, reduce length of hospital stay and decrease time spent on parenteral nutrition. No studies looked
at longer-term outcomes of the interventions (i.e. beyond six months). Studies have reported no effect on breast feeding outcomes nor
on weight gain.
Quality of evidence
These studies were small and most were of low or very low methodological quality. Review authors identified no high-quality studies
that could support the efficacy, effectiveness and safety of oral stimulation interventions. Larger, well-designed RCTs are needed to help
inform parents and caregivers about the possible benefits and harms of this intervention.

Oral stimulation for promoting oral feeding in preterm infants (Review) S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]
Comparison group 1
Patient or population: preterm inf ants

Setting: NICU
Intervention: oral stim ulation
Comparison: standard care
Outcomes Anticipated absolute effects* (95% CI) Relative effect No. of participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)
Risk with standard care Risk with oral stimula-

tion
Days to f ull oral f eeding M ean days to f ull oral M ean days to f ull oral - 376 ⊕⊕ Heterogeneity (I 2 = 68%)
f eeding: 0 f eeding in the interven- (8 RCTs) Low a,b,c,d,e,f,g,h between these studies
tion group: 5.22, unde- was substantial, with
f ined lower (6.86 lower high risk of bias overall
to 3.59 lower) between them
Weight gain M ean weight gain: 0 M ean weight gain in the - 81 ⊕⊕

intervention group: 0. (2 RCTs) Low a,b,e,f,g
05, undef ined lower (1.
19 lower to 1.09 higher)
Total hospital stay M ean total hospital M ean total hospital - 301 ⊕
(days) stay (days): 0 stay (days) in the in- (7 RCTs) Very low a,b,c,d,e,f
tervention group: 5.26,
undef ined lower (7.34
lower to 3.19 lower)
Duration (days) of par- M ean duration (days) of M ean duration (days) of - 19 ⊕

enteral nutrition parenteral nutrition: 0 parenteral nutrition in (1 RCT) Very low a,b,c,f
the intervention group:
5.3, undef ined lower (9.
73 lower to 0.87 lower)
4
Exclusive direct breast 350 per 1000 641 per 1000 RR 1.83 (0.96 to 3.48) 59 ⊕
f eeding at discharge (366 to 847) (1 RCT) Very low a,b,c,e
Any direct breast f eed- 348 per 1000 431 per 1000 RR 1.24 110 ⊕
ing at discharge (202 to 925) (0.58 to 2.66) (2 RCTs) Very low a,b,c,d
* The risk in the intervention group (and its 95% conf idence interval) is based on the assum ed risk in the com parison group and the relative effect of the intervention (and its
95% CI).
CI: conf idence interval; OR: odds ratio; RR: risk ratio.
GRADE Working Group grades of evidence

High quality: We are very conf ident that the true ef f ect lies close to that of the estim ate of ef f ect.
M oderate quality: We are m oderately conf ident in the ef f ect estim ate: The true ef f ect is likely to be close to the estim ate of ef f ect but m ay be substantially dif f erent.
Low quality: Our conf idence in the ef f ect estim ate is lim ited: The true ef f ect m ay be substantially dif f erent f rom the estim ate of ef f ect.
Very low quality: We have very little conf idence in the ef f ect estim ate: The true ef f ect is likely to be substantially dif f erent f rom the estim ate of ef f ect
a High risk of selection bias.
b High risk of perf orm ance bias.
c High risk of detection bias.
d
Substantial heterogeneity (50% to 90%).
e High risk of attrition bias.
f High risk of reporting bias.
g M oderate heterogeneity (30% to 60%).
h Considerable heterogeneity (75% to 100%).
5
Should feeding commence earlier in this population, estimated
BACKGROUND
economic data identify potential cost savings in the USA rang-
Preterm infants, particularly very preterm (< 32 weeks’) infants, ing from $3500 (Field 1982) to $280 million in hospitalisation
often have substantial delays in attaining independent oral feeding charges per infant for board alone (Daley 2000). More recent fig-
(American Academy of Pediatrics 2008; Eichenwald 2001; Engle ures estimate that a three-day decrease in hospital stay for this
2007; Jadcherla 2010). Acquiring the skills needed for safe oral population could result in savings of more than two billion dollars
feeding is a complex process, and very preterm infants frequently annually (Lessen 2011).
have lengthy initial hospital stays until they can demonstrate the
ability to show feeding and satiation cues; sustain suck, swallow
and breathing throughout oral feeding; and maintain nutritional Description of the condition
intake to support growth and development (Lau 2000a; Lau 2011;
Oral feeding is a complex skill that requires the integration of
MacMullen 2000; Premji 2004). Several factors help to promote
breathing, sucking and swallowing in the context of overall motor
maturation, including practice, co-ordination, increased strength
stability and incoming sensory stimuli (Arvedson 2010; da Costa
and decreased fatigue (Amaizu 2008; Cunha 2009; Joung 2006;
2010a; Fadavi 1997; Kelly 2007; Lau 2000a; Lefton-Greif 2007;
Lau 2000a). Although maturation of oral feeding functions will
Ross 2002). This skill depends upon brainstem central pattern
enhance their performance, it is co-ordination of these activities
generators, whose activity is influenced by chemosensory and oral
in conjunction with swallowing and respiratory control that will
tactile input (Amaizu 2008; Bingham 2009; Lau 2011; Lau 2015;
ultimately lead to ‘readiness to oral feed’ in a safe and efficient
Wolf 1992). The ability to progress to successful feeding depends
manner (Lau 2011).
on the infant’s ability to co-ordinate the muscles of the jaw, lips,
Development can be significantly disrupted by comorbidities tongue, palate and pharynx, upper trunk and respiratory systems
present in preterm infants, such as respiratory disease (Lau 2015; to support a safe swallow. It is also dependent on normal sensory
Mandich 1996; Miller 2007), brain injury (Medoff-Cooper 1996) functioning seen in primitive reflexes such as rooting, gag and an
and necrotising enterocolitis (NIH 2008), which limit opportu- intact swallow reflex and intraoral and pharyngeal sensation.
nities for sucking and deprive the infant of essential sensory and Researchers have described the developmental stages of sucking in
motor experiences during a critical period of brain development preterm infants during oral feeding (Amaizu 2008; Cunha 2009;
when the central patterning of suck and feeding skill is refined (da Dodrill 2008b; Lau 2000a; Medoff-Cooper 1993; Neiva 2007
Costa 2010b; da Costa 2010c; Howe 2007; Mizuno 2007; Stumm (an additional reporting of Neiva 2006)). Varying components of
2008; Thoyre 2003a; Thoyre 2003b). Medical interventions used sucking physiology, such as sucking amplitude, rate and pressure
with preterm infants, such as prolonged endotracheal intubation intensity; timing of sucking cycles; and proficiency and efficiency
(Bier 1993), continuous positive airway pressure (CPAP), nasal (Bingham 2009; Lau 2011; Medoff-Cooper 2000; Neiva 2007
cannulation and regular oropharyngeal, nasal or tracheal suction (an additional reporting of Neiva 2006); Poore 2008a; Stumm
(White-Traut 2005) may result in negative responses to oral feed- 2008), appear to mature over time at varying rates, depending
ing (Bingham 2009; Jadcherla 2010; Rocha 2007) and long-term on the factors outlined above (Amaizu 2008; Lau 1997; Pickler
oral sensitivity (Dodrill 2004). Other factors, such as prefeeding 2006). Experience with oral feeding appears to have a positive
behaviour state, feeding readiness and feeding experience, also in- effect on the characteristics of sucking (Cunha 2009; Pickler 2006;
fluence feeding performance in preterm infants (Burklow 2002; Simpson 2002). One analysis of nutritive sucking function in very
Dodrill 2008a; Howe 2007; Joung 2006; Kinneer 1994; Pickler low and extremely low birth weight infants outlines how weakness
2006). of oral muscular function and minimal sucking skill can bring
about weakness of intensity of sucking pressure, decreased time
Few preterm infants are adequate oral feeders from birth, and of the sucking stage in a sucking cycle and unstable intensity of
many receive enteral feeds by tube, necessitating longer hospital sucking pressure and time, causing low efficiency of milk intake
stays as they transition from tube (gavage) feeds to oral feeds. and smaller amounts of milk swallowed during each sucking period
Occasionally, preterm infants do not have adequate oral intake at (Matsubara 2005). These problems lasted longer in an extremely
term corrected age, and they remain partially or exclusively tube fed low birth weight group than in a small group of full-term infants.
for months or years. Pathways for facilitating the transition from The presence of a persistently disorganised sucking pattern after
tube to oral feeding in this population can vary between centres 37 weeks can be predictive of neurodevelopmental outcomes at
and are dependent on a variety of factors, such as age, weight, oral six months and 12 months (Tsai 2010). Although enteral milk
motor skills, feeding techniques and feeding experience (Cowen feeding is critical for their optimal growth and development, few
2006; Dougherty 2008; Howe 2007). Initiation of oral feeding is preterm infants feed adequately orally from birth. Consequently,
often based on infant weight and postmenstrual age (PMA), but these infants remain tube fed in hospital for protracted periods as
empirically derived guidelines for starting or progressing oral feeds they learn to feed orally, contributing to increased healthcare costs
are not available (Crowe 2006; Dodrill 2008c; Pickler 2006). and heightened family stress (Swift 2010).

Description of the intervention may be overwhelming and may increase stress and risk of aspira-
tion of oral secretions (Wolf 1992).
The intervention programmes referred to earlier in this review
are designed to facilitate the development of oral motor and sen-
sory skills required for sucking and swallowing. Such direct pro-
grammes often involve stroking perioral and intraoral structures in
a specific way with a gloved finger for a specified time before feed- Why it is important to do this review
ing (Fucile 2002; Fucile 2002a; Fucile 2011; Lessen 2009; Pimenta Several other systematic reviews and meta-analyses (Arvedson
2008). Techniques such as stroking the cheeks are reported to en- 2010; Crowe 2006 Daley 2000; Pinelli 2005) have studied gen-
hance the sucking rate, and providing cheek and chin/jaw support eral approaches to feeding, including use of pacifiers, but none
may facilitate sucking efficiency during feeding (Boiron 2007). has yet evaluated the evidence for specific oral stimulation inter-
Positive effects on the rhythm of pharyngeal swallowing in re- ventions based on finger stimulation protocols. Previous reviews
sponse to oral sensorimotor programmes have been described (Bo- have had a broad scope, resulting in wide heterogeneity and vari-
iron 2009, an additional reporting of Boiron 2007). Many of the ability among participants, interventions and outcome measures
interventions described involve some level of training and require (Arvedson 2010; Daley 2000), or review authors have looked only
skilled delivery by a nurse, an occupational therapist, a speech and at non-nutritive sucking activities (Cowen 2006; Pinelli 2005).
language therapist, a parent or other developmental specialists. Therefore, this review will compare only finger stimulation pro-
tocols as oral stimulation interventions and will determine their
effects on outcomes such as neonatal intensive care unit (NICU)/
How the intervention might work hospital discharge, time to attainment of oral feeding, duration of
parenteral feeding, suck/swallow maturation and anthropometri-
These interventions are designed to reduce oral hypersensitiv- cal measures such as weight gain, length and head circumference.
ity, improve range of motion and strength of muscles for suck- For the purposes of this review, we have revised the definition of
ing (Fucile 2002), increase oral motor organisation (Case-Smith oral stimulation from that proposed in the protocol (Greene 2012)
1989) and activate reflex behaviours that facilitate nutritive suck- (see Differences between protocol and review). Oral stimulation
ing (Leonard 1980; Neiva 2007 (an additional reporting of Neiva is currently defined as direct delivery of sensory stimulation by a
2006)). In general, these techniques aim to normalise sensation by finger stroking protocol to the perioral and/or oral area, designed
restoring reflexes and in turn elicit normal oral movements of lips, to elicit movement responses in the lips, jaw, soft palate, pharynx,
tongue, jaw and pharynx for development of sucking and swallow- larynx and respiratory muscles to influence oropharyngeal and res-
ing. As well as facilitating the development of oral skills for even- piratory sensorimotor mechanisms, to improve function for suck-
tual feeding, these interventions provide such beneficial effects as ing and feeding in preterm infants. Oral stimulation should occur
accelerated transition from tube feeding to independent oral feed- before or during nutritive sucking (NS) and non-nutritive sucking
ing (McCain 2001; Pinelli 2005), enhanced sucking maturation (NNS) events with tube feeds.
(Boiron 2007; Harding 2006; Leonard 1980; Poore 2008b), earlier It is unclear whether oral stimulation interventions, specifically
achievement of oral feeding (Boiron 2007; Harding 2006), reduc- those using finger stimulation protocols, result in earlier exclu-
tion in bottle feeding stress (Pickler 1992), increased volume in- sive oral feeding in preterm infants. It is important to determine
take (Boiron 2007; Einarsson-Brackes 1994), greater weight gain whether exclusive oral feeding as a result of this intervention con-
(Bernbaum 1983; Gaebler 1996) and fewer days of hospitalisation tributes to earlier NICU discharge and subsequent hospital dis-
(Gaebler 1996; Harding 2006; Johnston 1999; Pinelli 2005). charge. This review is important because it will (1) assist health-
Although no adverse effects of these interventions have been re- care providers in clarifying policy related to implementing treat-
ported to date, effects that may be observed as indicators of feeding ment for preterm infants in appropriate clinical settings and (2)
stress in this group include heart rate variability (McCain 1995; assist in promoting evidence-based practice internationally in the
McCain 2010) and apnoeic episodes associated with feeding-in- treatment of preterm infants.
duced apnoea (Eichenwald 2001; Howe 2007; Thoyre 2003a; If these interventions are found to be effective, they could become
Thoyre 2003b). Other possible adverse effects include oral trauma a routine and standard part of delivery of care to preterm infants
to the mouth, oral infection or both. Silent aspiration of oral feeds in NICU settings, facilitating earlier discharge and reducing costs
is an ongoing concern that needs careful monitoring in this group of care associated with long hospital stay.
(Miller 2007). The introduction of any implement or device into
the oral cavity can cause an increase in salivary flow rate. For
preterm infants who display weakness and inco-ordination in the
oropharyngeal system, and are unable to consistently control and
swallow their own saliva, the sudden increase in saliva associated
with the introduction of a soother or a gloved finger, for example, OBJECTIVES

Primary objectives Types of interventions
To examine the effectiveness of oral stimulation interventions for We included all trials involving oral stimulation interventions that
attainment of oral feeding in preterm infants born before 37 weeks’ occurred in any clinical setting with delivery by a trained person
postmenstrual age (PMA). or team, including nurse, occupational therapist, speech and lan-
To conduct subgroup analyses for the following prespecified sub- guage therapist, other developmental specialist or parent. We con-
groups. sidered any dosage, intensity, frequency, duration and timing of
• Extremely preterm infants born at < 28 weeks’ PMA. delivery of interventions. We made the following comparisons.
• Very preterm infants born from 28 to < 32 weeks’ PMA. • Oral stimulation intervention versus no intervention or
• Infants breast fed exclusively. standard care or sham treatment.
• Infants bottle fed exclusively. • Oral stimulation intervention versus non-oral intervention.
• Infants who were both breast fed and bottle fed. • Oral stimulation intervention versus other oral stimulation
delivered by a different method (e.g. dosage/intensity, frequency,
duration and/or timing of delivery, mode of delivery, personnel
delivering the intervention).
METHODS Types of outcome measures

We considered the following outcome measures as potential mea-
sures of success: outcome measures that signified improvement in
Criteria for considering studies for this review feeding ability and oromotor function of the preterm infant and
that reduced NICU and/or overall hospital stay.
Types of studies Primary outcomes
We included all published and unpublished randomised controlled • Time (days) taken to achieve exclusive oral feeding, defined
trials (RCTs) and quasi-randomised controlled trials reported in as ingestion of all nutrient volumes in a 24-hour period without
any language. We classified as RCTs all trials that involved at least gavage (McCain 2001)
one test treatment aimed at improving oral motor function and • Time (days) spent in NICU
one control treatment, with concurrent enrolment and follow-up • Total hospital stay (days)
of both test-treated and control-treated groups. We classified as • Duration (days) of parenteral nutrition
quasi-RCTs all trials that involved at least one test treatment aimed
at improving oral motor function and one control treatment, with Secondary outcomes
concurrent enrolment and follow-up of test-treated and control- • Exclusive oral feeding at 40 weeks’ PMA
treated groups, when the method of allocation was known but was • Exclusive direct breast feeding at 40 weeks’ PMA
not considered strictly random, for example, alternate allocation
• Any direct breast feeding at 40 weeks’ PMA
by day or date of birth or medical record number. We excluded
• Weight gain (g/kg/d)
cross-over trials.
• Length (cm/d)
• Head circumference (cm/d)
• Maturation in sucking strength (measured by rate of milk
Types of participants intake (mL/min); suction amplitude (mmHg)/sucks/min)
We included all trials of preterm infants of mixed ages in which the • Developmental outcomes ascertained by a validated
data allowed for extraction of participants up to 37 weeks’ PMA. instrument at 12 to 18 months
The intervention could occur at any time from date of birth. We • Adverse outcomes, such as sepsis, oral infection, oral
did not exclude trials that included infants with comorbid im- trauma, apnoea or bradycardia episodes requiring intervention
pairments, such as neurological or structural impairments. Partic- from the caregiver (stimulation, oronasal suction, increased
ipants had to be deemed medically stable for the intervention. We delivery of oxygen, assisted ventilation), increased salivary flow
excluded participants who presented with defined respiratory dis- (as measured by the presence of saliva beyond the level of the
ease, as this particular subgroup is at increased risk of feeding dis- lips), oxygen dependence at 36 weeks’ PMA, death during initial
orders, and comparison between these infants and healthy preterm hospital stay
infants is difficult. We excluded trials of infants presenting with • Necrotising enterocolitis (≥ Bell’s stage 2)
significant comorbid conditions that preclude the introduction of • Retinopathy of prematurity (any stage and ≥ stage 3)
oral feeding. • Family satisfaction with intervention

• Non-compliance with intervention Abstracts for the following organisations were available via stan-
dard databases through our online searches.
We considered three time frames for follow-up. • American Dysphagia Research Society (DRS) and
• Immediate change. European Society for Swallowing Disorders (ESSD): Dysphagia
• Medium-term change (three to six months). Journal, from 1992 to 2016.
• Long-term change (beyond six months). • American Academy of Pediatrics: Paediatrics, Hospital
Paediatrics.
• American Society for Parenteral and Enteral Nutrition
Search methods for identification of studies (ASPEN): Journal of Parenteral and Enteral Nutrition, Nutrition
in Clinical Practice.
We included in the review published and unpublished studies of
trials on humans reported in any language. • European Society for Swallowing Disorders (ESSD):
Dysphagia Journal, DRS above.
• Canadian Pediatric Society.
Electronic searches
We used the criteria • European Academy of Paediatrics: European Journal of
and standard methods of The Cochrane Collaboration and the Paediatrics, online archive from 2011 to 2016.
Cochrane Neonatal Review Group (see the Cochrane Neonatal • European Society for Paediatric Research: Pediatric
Group search strategy for specialized register). Research, online archive from 1967 to 2016.
We conducted a comprehensive search that included the Cochrane Personal communication with other relevant groups was not con-
Central Register of Controlled Trials (CENTRAL; 2016, Issue sidered necessary.
1), in The Cochrane Library; MEDLINE via PubMed (1966 to
current); Embase (1980 to current); and the Cumulative Index
to Nursing and Allied Health Literature (CINAHL; 1982 to cur-
Data collection and analysis
rent), using the following search terms: ((non-nutritive suck*) OR
pacifier OR dummy OR (myofunctional therapy) OR oromotor
OR (oral motor) OR sensorimotor OR ((suck OR oral OR orocu-
Selection of studies
taneous OR physical OR mechanical OR sensory OR somatosen-
sory OR pre-feeding) AND (stimulation OR training OR sup- We merged search results using reference management software
port)) AND (feed* OR growth)), (Note: Growth was included as a (RefWorks) and removed duplicate records. Two review authors
term only in The Cochrane Library), plus database-specific limiters (ZG, MW) used a screening form to individually examine the titles
for RCTs and neonates (see Appendix 2 for the full search strategy and abstracts of identified studies. We classified studies for this
for each database). We applied no language restrictions. review as ’include’, ’unsure’ or ’exclude’. We excluded reports that
We searched clinical trials registries for ongoing and recently clearly did not meet the inclusion criteria and were not relevant. We
completed trials (clinicaltrials.gov; the World Health Organiza- resolved disagreements on inclusion of studies through discussion.
tion International Trials Registry and Platform www.whoint/ictrp/ All review authors independently reviewed full texts of reports
search/en/ and the ISRCTN Registry). identified as ’include’ or ’unsure’. We resolved disagreements on
compliance with eligibility criteria through discussion. We deter-
mined that it was not necessary to contact any study authors.
Searching other resources
We checked published abstracts from the following organisations. Data extraction and management
• American Speech-Language-Hearing Association:
We used a specifically devised data extraction form to extract data
Perspectives Special Interest Group 13 (2001 to 2016).
from study reports (Greene 2012). All review authors indepen-
• Royal College of Speech and Language Therapists (1999 to dently extracted data from each report to minimise errors and re-
2016). duce potential risk of bias. We resolved disagreements through
• Neonatal Society via www.neonatalsociety.ac.uk (2001 to discussion.
2016).
• British Association of Perinatal Medicine (guidelines/ Assessment of risk of bias in included studies
reports/newsletters only) (2003 to 2016). We analysed each study individually for bias across the five do-
• Conference on Feeding and Eating in Infancy and Early mains of bias and added this information to the Characteristics
Childhood, Institute of Child Health Great Ormond Street of included studies table. We evaluated the following issues and
(2010 to 2016). entered this information into the risk of bias table (Higgins 2008).

Sequence generation (checking for possible selection bias) When sufficient information was reported or supplied by the trial
Was the allocation sequence adequately generated? authors, we included this missing data in the analyses and cate-
For each included study, we considered the method used to gen- gorised the method as:
erate the allocation sequence as: • adequate (< 20% missing data);
• adequate (any truly random process, e.g. random number • inadequate (≥ 20% missing data); or
table, computer random number generator); • unclear.
• inadequate (any non-random process, e.g. odd or even date
of birth, hospital or clinic record number); or Selective reporting bias
• unclear.
Are reports of the study free of the suggestion of selective outcome
reporting?
Allocation concealment (checking for possible selection bias) For each included study, we described how we investigated the
Was allocation adequately concealed? possibility of selective outcome reporting bias and what we found.
For each included study, we considered the method used to conceal We assessed methods as:
the allocation sequence as: • adequate (when it is clear that all of the study’s prespecified
• adequate (e.g. telephone or central randomisation, outcomes and all expected outcomes of interest to the review
consecutively numbered sealed opaque envelopes); have been reported);
• inadequate (e.g. open random allocation, unsealed or non- • inadequate (when not all the study’s prespecified outcomes
opaque envelopes, alternation, date of birth); or have been reported; when one or more reported primary
• unclear. outcomes that were not prespecified outcomes of interest are
reported incompletely and so cannot be used; when the study
fails to include results of a key outcome that would have been
Blinding (checking for possible performance bias) expected to have been reported); or
Was knowledge of the allocated intervention adequately prevented • unclear.
during the study? At study entry? At the time of outcome assess-
We also considered other issues that may affect reporting bias,
ment?
such as publication, time lag, language, duplicate publication and
For each included study, we considered the methods used to blind
citation.
study participants and personnel from knowledge of which in-
tervention a participant received. We assessed blinding separately
for different outcomes or different classes of outcomes. We cate- Other sources of bias
gorised methods as: Was the study apparently free of other problems that could put it
• adequate, inadequate or unclear for participants; at high risk of bias?
• adequate, inadequate or unclear for personnel; or For each included study, we described important concerns that we
• adequate, inadequate or unclear for outcome assessors. had about other possible sources of bias (e.g. whether we noted a
potential source of bias related to the specific study design, whether
Incomplete outcome data (checking for possible attrition the trial was stopped early because of some data-dependent pro-
bias through withdrawals, dropouts, protocol deviations) cess). We assessed whether each study was free of other problems
that could put it at risk of bias as:
Were incomplete outcome data adequately addressed?
• yes;
For each included study and for each outcome, we described com-
• no; or
pleteness of data, including attrition and exclusions from the anal-
• unclear.
ysis. We noted whether attrition and exclusions were reported, the
numbers included in the analysis at each stage (compared with the If needed, we planned to explore the impact of the level of bias by
total number of randomised participants), reasons for attrition or undertaking sensitivity analyses.
exclusion when reported and whether missing data were balanced We created a ’Risk of bias’ table for each study in Review Manager
across groups or were related to outcomes. 5.3 (RevMan 2015) (Figure 1).

Figure 1. Risk of bias summary: review authors’ judgements about each risk of bias item for each included
study.

and presence of publication bias. We used the GRADEpro Guide-
line Development Tool to create a ‘Summary of findings’ table to
Measures of treatment effect
report the quality of the evidence.
We calculated risk ratio (RR) and risk difference (RD) for dichoto- The GRADE approach results in an assessment of the quality of
mous data, and mean difference (MD) for continuous data, with a body of evidence in one of four grades:
respective 95% confidence intervals (CIs), in Review Manager 5.3 1. High: We are very confident that the true effect lies close to
(RevMan 2015). that of the estimate of the effect.
2. Moderate: We are moderately confident in the effect
estimate: the true effect is likely to be close to the estimate of the
Unit of analysis issues
effect, but there is a possibility that it is substantially different.
The unit of analysis was the individual preterm infant. 3. Low: Our confidence in the effect estimate is limited: the
true effect may be substantially different from the estimate of the
effect.
Dealing with missing data
4. Very low: We have very little confidence in the effect
We planned to contact study authors to seek missing data if we estimate: the true effect is likely to be substantially different from
judged that these data would be useful for the review. the estimate of effect.
Assessment of heterogeneity Subgroup analysis and investigation of heterogeneity

If more than one trial was included in a meta-analysis, we examined If sufficient data were available, we planned to undertake subgroup
the treatment effects of individual trials and heterogeneity between analyses of:
trial results by inspecting the forest plots. We calculated the I² • infants born at < 28 weeks’ PMA;
statistic for each analysis to quantify inconsistency across studies • infants born from 28 to < 32 weeks’ PMA;
and to describe the percentage of variability in effect estimates that • infants breast fed exclusively;
may be due to heterogeneity rather than to sampling error. • infants bottle fed exclusively; and
• infants who were both breast fed and bottle fed.
Data synthesis
We performed meta-analyses when data were presented with suf- Sensitivity analysis
ficient information. We used mean difference (MD) for continu- We planned to perform sensitivity analyses based on methodolog-
ous outcomes when analysing interventions and outcomes of suf- ical quality.
ficient homogeneity. For dichotomous outcomes, we used risk ra-
tio (RR) and risk difference (RD) and the fixed-effect model for
meta-analysis.
RESULTS
Quality of evidence
We used the Grading of Recommendations Assessment, Devel- Description of studies
opment and Evaluation (GRADE) approach, as outlined in the
GRADE Handbook (Schünemann 2013), to assess the quality of
evidence for the following (clinically relevant) outcomes: days to Results of the search
full oral feeding, weight gain, days of parenteral nutrition, total The search yielded 2252 studies after duplicates were excluded
hospital stay (days), exclusive direct breast feeding at discharge and (Figure 2). Screening of titles resulted in 94 trials for further
any direct breast feeding at discharge. scrutiny. Review authors determined that 17 studies were poten-
Two authors independently assessed the quality of the evidence tially eligible for inclusion in the review. On further inspection
for each of the outcomes above. We considered evidence from at data extraction, we had to exclude the stage 1 study, as data
randomized controlled trials as high quality but downgraded the could not be extracted in relation to infants under 37 weeks’ PMA
evidence one level for serious (or two levels for very serious) limi- (Howard 2003). Therefore, a total of 16 studies were eligible for
tations based upon the following: design (risk of bias), consistency full data extraction. All studies were published in English. Search-
across studies, directness of the evidence, precision of estimates ing of conference proceedings revealed no abstracts apart from

the ASHA (American Speech-Language-Hearing Association) Per-
spectives Special Interest Group 13 (2001 to 2016), for which a
separate online search revealed 73 abstracts; we identified six as
relevant to this topic, but all were reviews or summaries of the lit-
erature, and we excluded them on this basis (Gosa 2006; Faherty
2006; Lau 2014; Ross 2008b; Shaker 2010; Sheppard 2005).

Figure 2. Study flow diagram.

readiness was demonstrated until all feeds were given orally. This
Included studies
was done three times daily. The stimulation protocols reported
See Characteristics of included studies. by Neiva 2006 were vague and were not replicable; investigators
We included 16 RCTs (no quasi-RCTs) that enrolled between 14 simply stated that groups received no stimulation, received non-
and 108 participants, for a total of 825 participants. nutritive sucking with a pacifier or received stimulation of non-
All trials reported finger stimulation protocols before feeds (gavage nutritive sucking with a gloved finger. Stimulation was done daily
or oral) with or without other supports. Broadly, these fell into for 10 minutes, except on weekends. The finger stimulation pro-
two comparison types (Table 1). tocol described by Boiron 2007 differs again from those described
• Oral stimulation versus no intervention or standard care above, involving a 12-minute finger stimulation programme with
(Bala 2016; Boiron 2007; Gaebler 1996; Harding 2006; Harding or without oral support during feeding. The protocol was deliv-
2014; Lyu 2014; Neiva 2006; Younesian 2015; Zhang 2014). ered once a day 30 minutes before gavage feeds for the last 14 con-
• Oral stimulation versus another non-oral stimulation secutive days of gavage feeds. Lessen 2011 described a five-minute
intervention (Asadollahpour 2015; Fucile 2002; Fucile 2011; oral motor programme delivered from 29 weeks’ PMA once a day
Fucile 2012; Lessen 2011; Pimenta 2008; Rocha 2007). for seven consecutive days.
No studies assessed an oral stimulation intervention versus another
oral stimulation intervention that differed in method (e.g. dosage/ Outcomes
intensity, frequency, duration and/or timing of delivery, mode of
Most trials reported outcome observations only for the short term
delivery, personnel delivering the intervention).
(i.e. on discharge from NICU), with the exception of Pimenta
2008, which followed groups up to six months of age. Several pri-
Interventions mary and secondary outcome measures were not reported by any
studies (i.e. time (days) spent in NICU (one of our primary out-
comes)), and secondary outcomes included direct breast feeding at
’Fucile protocol’ term corrected age, developmental outcomes at 12 to 18 months
of age, retinopathy of prematurity, family satisfaction and non-
Nine trials replicated the 15-minute finger stimulation protocol
compliance with the intervention. Harding 2014 reported follow-
described by Fucile 2002 as their primary oral stimulation inter-
up at six months. Researchers noted numerous hospital readmis-
vention (Asadollahpour 2015; Fucile 2011; Fucile 2012; Harding
sions, problems with oral feeding within that time frame and re-
2014; Lyu 2014; Pimenta 2008; Rocha 2007; Younesian 2015;
ceptive and expressive language ratings on the Preschool Language
Zhang 2014). This ’Fucile protocol’ is a clearly described prefeed-
Scales - a standardised and validated assessment tool - but these
ing finger stimulation protocol that involves 12 minutes of struc-
did not fall within the remit of our outcome measures.
tured finger stroking and three minutes of pacifier sucking (i.e. 15
minutes once a day for one consecutive day one to 30 minutes
before a tube feeding). Researchers clearly describe a sham stimu- Excluded studies
lation for the control group.
See Characteristics of excluded studies.
Interventions in other trials Risk of bias in included studies

The other studies reported a range of interventions that differed in Review authors noted variable risk of bias across all studies across
dose, frequency and method of delivery. Bala 2016 used an inter- all domains, with generally poorly described randomisation meth-
vention described by Hwang 2010 - a five-minute prefeeding oral ods and poor allocation concealment and blinding of participants
stimulation programme delivered before feeds five times a day, in- and outcome assessors (Figure 1). Only three studies performed
volving three minutes of manual perioral and intraoral stimulation, reasonably well across the seven domains in terms of adequate se-
followed by two minutes on a pacifier. Gaebler 1996 described a quence generation; adequate blinding of participants, personnel
different five-minute oral stroking protocol that was completed and outcome assessors; reports of complete data; and apparent low
three times daily, five days a week, before feeds. Harding 2006 risk of selective reporting (Harding 2006; Pimenta 2008; Rocha
described another finger stimulation protocol delivered by parents 2007). The risk of bias graph (Figure 1) shows high risk of bias
by which a finger or a pacifier could be used to elicit non-nutri- across the 16 studies for allocation concealment, blinding of par-
tive sucking, then the finger or pacifier remained in the infant’s ticipants and personnel, blinding of outcome assessment and in-
mouth for the first 10 minutes of tube feeding from when feeding complete outcome data.

Allocation Selective reporting
Seven studies adequately described their random sequence genera- Seven trials had low risk of reporting bias (Asadollahpour 2015;
tion methods (Bala 2016; Boiron 2007; Fucile 2002; Fucile 2011; Bala 2016; Boiron 2007; Gaebler 1996; Harding 2006; Harding
Harding 2006; Harding 2014; Zhang 2014). We could not de- 2014; Rocha 2007); remaining studies had unclear or high risk of
termine the method used in the other 12 studies. Only one study reporting bias.
described adequate allocation concealment (Pimenta 2008). We
could not determine allocation concealment in 15 studies. Eight
studies had unclear methods of allocation (Fucile 2002; Fucile Other potential sources of bias
2011; Fucile 2012; Gaebler 1996; Harding 2006; Rocha 2007;
Younesian 2015; Zhang 2014), and seven provided a poor or no Four trials had other biases (Boiron 2007; Fucile 2012; Gaebler
description of allocation (Asadollahpour 2015; Bala 2016; Boiron 1996; Neiva 2006). It was unclear whether other sources of bias
2007; Harding 2014; Lessen 2011; Lyu 2014; Neiva 2006). were present in the remainder.
Blinding
Effects of interventions
Only five studies described blinding of participants and personnel
(Fucile 2002; Fucile 2011; Pimenta 2008; Rocha 2007; Zhang See: Summary of findings for the main comparison Summary
2014). Only six studies described blinding of outcome assessors of findings table 1. Oral stimulation intervention versus standard
(Fucile 2002; Fucile 2011; Lyu 2014; Pimenta 2008; Rocha 2007; care; Summary of findings 2 Summary of findings table 2. Oral
Zhang 2014). stimulation intervention versus other non-oral intervention
Incomplete outcome data Comparison group 1

Review authors noted missing data in several studies, particularly
in relation to behavioural data taken at every intervention and
adverse effects.Eight trials provided complete data (Asadollahpour
Days to full oral feeding
2015; Bala 2016; Boiron 2007; Gaebler 1996; Harding 2006;
Lessen 2011; Pimenta 2008; Rocha 2007). (Analysis 1.1; Figure 3)
Figure 3. Comparison group 1. Analysis 1.1. Days to full oral feeding.

Meta-analysis showed statistically significantly fewer days taken to
attain full oral feeding in the intervention groups (MD -4.81, 95% ogy to describe weight: Younesian 2015 described weight change
CI -5.56 to -4.06, I2 = 68%, eight trials, 376 infants). Four of these from four oral feeds a day/four to eight oral feeds a day/eight oral
studies (Harding 2014; Lyu 2014; Younesian 2015; Zhang 2014) feeds a day until discharge (grams), and Zhang 2014 described %
followed the ’Fucile protocol’, and the remaining studies (Bala weight gain. Therefore, we included only two studies in the meta-
2016; Boiron 2007; Gaebler 1996; Harding 2006) used a range analysis, which showed no significant effect of the intervention on
of different interventions. The GRADE rating for methodological weight gain (MD 0.73 grams, 95% CI -1.05 to 2.51 grams, I2 =
quality was low (Summary of findings for the main comparison). 41%, two trials, 81 infants).
The GRADE rating for methodological quality was low (Summary
of findings for the main comparison).
Weight gain
(Analysis 1.2)
Only two studies used ‘weight gain’ as an outcome measure Days in hospital
(Gaebler 1996; Lyu 2014). Other studies used varying terminol- (Analysis 1.3; Figure 4)
Figure 4. Comparison group 1. Analysis 1.3. Total hospital stay (days).
Meta-analysis showed that the intervention group had a statis-

tically significantly shorter hospital stay (MD -5.26 days, 95%
CI -7.34 to -3.19 days, I2 = 61%, seven trials, 301 infants). The
GRADE rating for methodological quality was very low (Summary
of findings for the main comparison).
Duration of parenteral nutrition (days)

(Analysis 1.4; Figure 5)
Figure 5. Comparison group 1. Analysis 1.4. Duration (days) of parenteral nutrition.

Lessen 2011 reported a statistically significant reduction in the
number of days of parenteral nutrition in the intervention group Any/Partial direct breast feeding on discharge
(MD -5.30, 95% CI -9.73 to -0.87). The GRADE rating for (Analysis 1.6)
methodological quality was very low (Summary of findings for the Meta-analysis did not show a statistically significant effect on any
main comparison). or partial direct breast feeding on discharge with the intervention
(RR 1.24, 95% CI 0.58 to 2.66, I2 = 60%, two trials, 100 infants).
The GRADE rating for methodological quality was very low (
Exclusive direct breast feeding on discharge Summary of findings for the main comparison).
(Analysis 1.5)
Harding 2014 did not show a statistically significant difference in
exclusive direct breast feeding on discharge with the intervention
Comparison group 2
(RR 1.83, 95% CI 0.96 to 3.48). The GRADE rating for method-
ological quality was very low (Summary of findings for the main
Time (days) to achieve exclusive oral feeding
comparison).
Figure 6. Comparison group 2. Analysis 2.1. Time (days) to achieve exclusive oral feeding.
Meta-analysis showed a statistically significant reduction in days

to achieve exclusive oral feeding with the intervention (MD -9.01
days, 95% CI -10.30 to -7.71, I2 = 25%, five trials, 256 infants).
The GRADE rating for methodological quality was low (Summary
of findings 2).
Days in hospital

Figure 7. Comparison group 2. Analysis 2.2. Total hospital stay (days).
Meta-analysis showed a statistically significant reduction in total

hospital stay (days) for the intervention group (MD -2.94, 95%
CI -4.36 to -1.51, I2 = 48%, six trials, 352 infants). The GRADE
rating for methodological quality was low (Summary of findings
2).
Duration (days) parenteral nutrition

Figure 8. Comparison group 2. Analysis 2.3. Duration (days) of parenteral nutrition.
Rocha 2007 showed a statistically significantly shorter duration of

parenteral nutrition in the intervention group (MD -8.70, 95% This outcome was not reported by any trials.
CI -15.46 to -1.94). The GRADE rating was low.
Weight gain Head circumference growth

No studies described ’weight gain’ as an outcome measure. This outcome was not reported by any trials.
Asadollahpour 2015 reported ’weight changes’, Fucile 2011 re-
ported ’weight at end of intervention’ and Rocha 2007 described
’weight at discharge (g)’; however, these researchers did provide
data for weight gain in the first and second weeks of the study for Exclusive direct breast feeding at discharge
each group (g/kg/d). Therefore, meta-analysis was not possible.
(Analysis 2.4)
Pimenta 2008 showed no statistically significant difference in ex-
clusive direct breast feeding at discharge with the intervention (RR
Length gain
0.96, 95% CI 0.72, 1.28). The GRADE rating was moderate.
Maturation in sucking strength Developmental outcomes ascertained by a validated
Twelve trials reported a wide variety of different and thereby in- instrument at 12 to 18 months
comparable suck, swallow and feeding measures, including suck- No data are available for this outcome.
ing pressure (mmHg), number of bolus feeds per day, percent-
age milk ingested daily, number of swallows per minute, number
Necrotising enterocolitis (≥ Bell’s stage 2)
of swallow bursts per minute, number of isolated swallows per
minute, rate of milk transfer (mL/min), sucking pattern matura- No data are available for this outcome.
tion, sucking frequency and amplitude, proficiency (% milk in first
five minutes of feed), volume transfer (% volume consumed/to-
Retinopathy of prematurity (any stage and ≥ stage 3)
tal), volume loss, stage of sucking at different time frames, suction
and expression amplitude; suck, swallow and respiratory co-ordi- No data are available for this outcome.
nation; % nipple feeds engaged in, Revised Neonatal Oral Motor
Assessment Scale (R-NOMAS) scores at days 1, 3 and 5; profi-
Family satisfaction with intervention
ciency (Gaebler 1996); NOMAS scores (Harding 2006; Harding
2014); oral feeding progression, oral feeding performance and effi- No data are available for this outcome.
ciency (Lyu 2014); easy beginning of sucking, labial sealing, suck-
ing rhythm, labial/tongue/jaw co-ordination (Neiva 2006); num-
Non-compliance with intervention
bers of bursts and pauses per minute, mean duration of bursts and
pauses, number of sucks per second (Neiva 2007, an additional No data are available for this outcome.
reporting of Neiva 2006); and rate of milk transfer (mL/min),
proficiency and volume transfer at days 1 and 4, and at end of trial
Adverse effects
(Zhang 2014).
No adverse effects such as sepsis, oral infection, oral trauma, ap-
noea or bradycardia episodes that require intervention from the
Length (cm/d) caregiver (stimulation, oronasal suction, increase in delivery of
oxygen, assisted ventilation), increase in salivary flow (as measured
No data are available for this outcome. by the presence of saliva beyond the level of the lips), oxygen de-
pendence at 36 weeks PMA or death during initial hospital stay
were reported. Many studies did report adverse effects of apnoea
Head circumference (cm/d) and bradycardia that were self-resolving and did not require inter-
No data are available for this outcome. vention other than cessation of the oral stimulation intervention.

Oral stimulation for promoting oral feeding in preterm infants (Review) A D D I T I O N A L S U M M A R Y O F F I N D I N G S [Explanation]
Comparison group 2
Patient or population: preterm inf ants

Setting: NICU
Intervention: oral stim ulation
Comparison: non-oral intervention
Outcomes Anticipated absolute effects* (95% CI) Relative effect Number of participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)
Risk with non- oral in- Risk with oral stimula-

tervention tion
Tim e (days) to achieve M ean tim e (days) to M ean tim e (days) to - 256 ⊕⊕ Heterogeneity (I 2 =
exclusive oral f eeding achieve exclusive oral achieve exclusive oral (5 RCTs) Low 1,4,5,6,7,8 25%) between studies
f eeding: 0 f eeding in the interven- was low, and issues
tion group: 9.01, unde- with selection, perf or-
f ined lower (10.3 lower m ance and attrition
to 7.71 lower) bias were noted
Total hospital stay M ean total hospital M ean total hospital - 352 ⊕⊕
(days) stay (days): 0 stay (days) in the in- (6 RCTs) Low 1,2,5,6
tervention group: 2.94,
undef ined lower (4.36
lower to 1.51 lower)
Duration (days) of par- M ean duration (days) of M ean duration (days) of - 98 ⊕⊕⊕ Only 1 study included
enteral nutrition parenteral nutrition: 0 parenteral nutrition in (1 RCT) Low Wide conf idence inter-
the intervention group: val
8.7, undef ined lower Not f ully blinded
(15.46 lower to 1.94
lower)
Exclusive direct breast 500 per 1000 479 per 1000 RR 0.96 (0.72 to 1.28) 196 ⊕⊕⊕ Only 1 study included
f eeding at discharge (346 to 617) (1 RCT) M oderate
21
* The risk in the intervention group (and its 95% conf idence interval) is based on the assum ed risk in the com parison group and the relative effect of the intervention (and its
95% CI).
CI: conf idence interval; OR: odds ratio; RR: risk ratio.
GRADE Working Group grades of evidence

High quality: We are very conf ident that the true ef f ect lies close to that of the estim ate of ef f ect.
M oderate quality: We are m oderately conf ident in the ef f ect estim ate: The true ef f ect is likely to be close to the estim ate of ef f ect but m ay be substantially dif f erent.
Low quality: Our conf idence in the ef f ect estim ate is lim ited: The true ef f ect m ay be substantially dif f erent f rom the estim ate of ef f ect.
Very low quality: We have very little conf idence in the ef f ect estim ate: The true ef f ect is likely to be substantially dif f erent f rom the estim ate of ef f ect
1 High risk of reporting bias.
2 M oderate heterogeneity (30% to 60%).
3 Substantial heterogeneity (50% to 90%).
4 Considerable heterogeneity (75% to 100%).
5
High risk of selection bias.
6 High risk of perf orm ance bias.
7 High risk of attrition bias.
8 Low heterogeneity (0 to 40%).
22
DISCUSSION For comparison group 1, the quality of the evidence ranged from
low (days to oral feeding, weight gain) to very low (total hospital
Preterm infants who received oral stimulation rather than usual stay, parenteral nutrition, breast feeding).
care took fewer days to attain full oral feeding (mean difference For comparison group 2, the quality of the evidence ranged from
(MD) -4.81, 95% confidence interval (CI) -5.56 to -4.06), had a moderate (duration of parenteral nutrition, exclusive direct breast
statistically significantly shorter hospital stay (MD -5.62, 95% CI feeding at discharge) to low (time to exclusive oral feeding, total
-7.34 to -3.19) and had a statistically significant reduction in the hospital stay, days of parenteral nutrition).
number of days of parenteral nutrition (MD -5.30, 95% CI -9.73
to -0.87). Oral stimulation intervention in this group appeared to
have no influence on breast feeding outcomes nor on weight gain
compared with usual care.
Potential biases in the review process
We strove to decrease biases in the review process. Two review
Infants who received oral stimulation had a statistically significant
authors (ZG, MW) individually examined the titles and abstracts
reduction in the number of days it took to achieve exclusive oral
of identified studies while using a screening form. All review au-
feeding (MD -8.81, 95% CI -10.05 to -7.58), a statistically signif-
thors were involved in the data extraction process. The Cochrane
icant reduction in total hospital stay (days) (MD -2.94, 95% CI
Neonatal Review Group was actively supportive at all stages from
-4.36 to -1.51) and a statistically significantly shorter duration of
designing the database search strategy and conducting the database
parenteral nutrition (MD -8.70, 95% CI -15.46 to -1.94) com-
search to providing advice on methods and making revisions to
pared with these outcomes following usual care. Oral stimulation
same.
intervention in this group did not appear to have an impact on
Our deviations from the protocol consisted of redefinition of oral
breast feeding outcomes.
stimulation interventions, re-scoping of the review focus and ap-
plication of the GRADE method in assessing the quality of evi-
Summary of main results dence. Our deviations from the protocol were unlikely to intro-
We identified 19 randomised controlled trials (RCTs) that were duce bias into the review process.
eligible for inclusion in this review. All were of low methodological
quality overall.
Investigators reported a range of oral stimulation interventions Agreements and disagreements with other
that appear beneficial for preterm infants in terms of reduced studies or reviews
length of hospital stay and earlier transition to oral feeding, with Not applicable.
reduced length of time on parenteral nutrition.
Overall completeness and applicability of AUTHORS’ CONCLUSIONS

evidence
The included studies reported positive outcomes involving length Implications for practice
of hospital stay, transition times from tube (gavage) to oral feed- Small studies with variable risk of bias and poor methodological
ing and duration of parenteral nutrition. These studies ranged in quality suggest that oral stimulation interventions shorten the time
size but most were small, and they were often poorly designed. taken for preterm infants to achieve exclusive oral feeding, reduce
Study results should be interpreted with caution and methodolog- length of hospital stay and reduce days on parenteral nutrition. The
ical limitations should be assessed when potential use of an inter- quality of these studies varied from moderate to very low; therefore,
vention is considered. findings should be interpreted with caution. It is apparent however
that using an oral stimulation intervention does have a statistically
significant positive influence on the outcomes reported, despite
Quality of the evidence varying levels of evidence, and should be considered for all infants
in the neonatal intensive care unit (NICU).
Trends in the data appear to indicate that providing an oral stimu-
lation intervention by a finger stimulation protocol reduces length
Implications for research
of hospital stay, time taken to achieve oral feeding and time spent
on parenteral nutrition, but all of the analyses are based on studies Well-designed studies of oral stimulation interventions for preterm
of limited methodological quality. Results of the data analysis are infants are warranted. Such studies should:
encouraging but must be interpreted with caution, given the high
risk of bias encountered across virtually all of the included studies. • clearly define the intervention;

• measure clinically important outcomes that are not limited relevant outcomes for suck and swallow maturation. The termi-
to those determined before hospital discharge; nology used to describe sucking and feeding skills should be made
more uniform, so studies can be more comparable and outcomes
more clinically relevant.
• enrol adequate numbers of infants to reliably determine a
difference in the primary outcome between groups;
• use a reliable of method of randomisation;

ACKNOWLEDGEMENTS
• conceal the treatment allocation;
Zelda Greene was supported by the Health Research Board (Ire-
• blind caregivers to treatment when possible; land), Cochrane Training Fellowship 2010.
• pay particular attention to blinding of outcome assessors; Yolanda Brosseau, Trials Search Co-ordinator for the Neonatal
and Group, provided advice and assistance in devising the search strat-
egy.
• report all outcomes.
Dr William Maguire, Hull York Medical School & Centre for
Methods used to assess sucking and feeding have not been stan- Reviews and Dissemination, University of York, UK, provided
dardised. This has led to lack of standardised reporting of clinically advice on methods.
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Journal of Neonatal Nursing 2008;14(1):9–16. Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Asadollahpour 2015
Methods Country: Iran

RCT
Three study groups. Randomisation method not fully described
No evidence of allocation concealment
Blinding of personnel delivering the intervention unclear
Blinding of outcome assessor unclear
Participants Preterm infants from 26 to 32 weeks of gestational age fed through a tube with birth
weight 1000 to 2000 grams
NNS intervention group: N = 11 (6 male/5 female), GA 30.18 ± 1.77 weeks, birth
weight 1406.36 grams
Prefeeding oral stimulation group: N = 10 (5 male/5 female), GA 30.01 ± 1.76, birth
weight 1343.01 grams
Control group: N = 11 (5 male/6 female), GA 30.29±1.95, birth weight 1393.63 grams
Interventions • NNS intervention: thrice-daily stroking of the palate for 5 minutes to elicit a
suck. This intervention was delivered by a speech and language therapist (SLT) who
was ’blinding to research’ and was performed through insertion of the SLT’s little finger
into infant’s oral cavity to gently stroke the hard palate to elicit a suck. NNS stimuli
were started during initial 5 minutes of tube feeding and were administered for 10
consecutive days. Protocol same as that described by Harding 2009
• Prefeeding oral stimulation intervention: performed by the same SLT. Oral
stimulation programme consisted of once-daily stroking of cheeks, gums and tongue,
followed by 3 minutes of non-nutritive sucking for 15 minutes. Protocol same as that
described by Fucile 2002
• Control: Group received sham intervention. For this group, the same SLT placed
her hands in the incubator without touching the infant for 15 minutes. This was
administered for 10 consecutive days
Outcomes Primary outcome: time to attain independent oral feeding

Secondary outcomes:
• Length of hospital stay
• Weight gain
Notes For birth weight, median values provided. Mean or standard deviation had to be calcu-
lated. Adverse events not recorded or reported
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection Unclear risk Random assignment was performed by ’a
bias) simple randomisation method’, whereby

Asadollahpour 2015 (Continued)
infants were randomly assigned to NNS (n

= 11), prefeeding oral stimulation (n = 10)
and control (n = 11) groups. This was not
clearly described
Allocation concealment (selection bias) High risk Despite study authors reporting, “This in-
tervention delivered by one speech ther-
apist who was blinding to research”, this
SLT delivered all interventions and there-
fore was aware of allocation in all groups
Blinding of participants and personnel High risk Same SLT delivered all interventions and
(performance bias) sham interventions and was not blinded
All outcomes
Blinding of outcome assessment (detection Unclear risk Weight was measured by ’a nurse’. It is un-
bias) clear whether the same nurse measured all
All outcomes infants, or whether the nurse on duty at the
time of weigh in performed the measure-
ments
Incomplete outcome data (attrition bias) Low risk All outcomes are reported. No data were
All outcomes missing.
Selective reporting (reporting bias) Low risk All of the study’s prespecified outcomes and
all expected outcomes of interest to the re-
view were reported
Other bias Unclear risk Information was insufficient to permit

judgement. Adverse events were not
recorded or reported
Bala 2016
Methods Country: India

RCT
Two study groups. Randomisation method described
No evidence of allocation concealment
Participants 51 healthy stable neonates who had reached full gavage feeding, were in transition from
gavage to spoon feeding and were receiving NNS and kangaroo mother care (KMC) as
routine care
Treatment group: 25 infants (10 male/15 female), gestational age 30.9 (1.7) weeks,
birth weight 1285 (283) grams
Control group: 26 infants (16 male/10 female), gestational age 30.3 (1.5) weeks, birth
weight 1212 (323) grams

Bala 2016 (Continued)
Interventions Intervention is not directly described, but Hwang 2010 is cited as a reference for the
protocol. Hwang 2010 describes a 5-minute programme modified from existing litera-
ture, which involves 3 minutes of manual perioral and intraoral stimulation, followed
by 2 minutes on a pacifier
Mothers were trained in oromotor stimulation (OMS) by principal investigator
Intervention group: OMS finger stimulation protocol plus standard care (NNS &
KMC) delivered by mothers trained on approach by PI
Control group: standard care described only as NNS and KMC
Outcomes Primary outcome: comparison of transition time from full gavage feed to partial and
full spoon feed
• Partial spoon feed was defined as accepting nearly 50% of the total volume of
milk by spoon and 50% by orogastric tube during each feed, and 1 to 2 full spoon
feeds in a day.
• Feeding efficacy was assessed by volume of total spoon feed intake (mL/kg/feed)
and by spoon feed intake rate per minute (mL/min).
Secondary outcome: assessment of total volume of milk by spoon at each feed and time
required to complete full spoon feed and partial direct breast feed at discharge
• Partial breast feed was defined as when baby was accepting full breast feed 5 to 6
times a day and the rest of feeds by spoon.
Notes Study authors report, “No harms or unintended effects like desaturation, aspiration,
apnoea, hypothermia, bradycardia, or infection were observed”
Risk of bias
Random sequence generation (selection Low risk Random assignment was performed with
bias) computer-generated random numbers
Sequentially numbered sealed opaque en-
velopes were opened by the principal in-
vestigator to assign infants to intervention
groups
Allocation concealment (selection bias) High risk Principal investigator was not blinded to
allocation.
Blinding of participants and personnel Unclear risk OMS was performed by mothers in the in-
(performance bias) tervention group. It is unclear whether they
All outcomes were blinded to group allocation
Blinding of outcome assessment (detection High risk Study authors state, “intervention and as-
bias) sessment could not be blinded due to its
All outcomes nature”
Incomplete outcome data (attrition bias) Low risk Outcomes are reported for all infants who
All outcomes achieved partial spoon feed, full spoon feed

Bala 2016 (Continued)
and partial breast feed at discharge
view have been reported

judgement.
Boiron 2007
Methods Country: France

RCT
Four study groups. Randomisation method described
Allocation concealment unclear
Participants 43 participants were recruited and participated in the study (23 males/20 females); all
were born between 29 and less than 34 weeks and entered the protocol at between 32
and less than 34 weeks GA; no older than 4 days of age
Treatment group 1 (stimulation and support): 9 participants (5 males/4 females), age
range 32 to 34 weeks, mean GA 31.3 weeks, mean birth weight 1718 grams
Treatment group 2 (stimulation): 11 participants (4 males/7 females), age range 32 to
24 weeks, mean GA 31.1 weeks, mean birth weight 1446 grams
Treatment group 3 (support): 11 participants (7 male/4 female), age range 32 to 34
weeks, mean GA 31.6 weeks, mean birth weight 1714 grams
Control group: 11 participants (7 male/4 female), age range 32 to 34 weeks, mean GA
31.1 weeks, mean birth weight 1442 grams
Interventions Treatment group 1: received oral stimulation and support

Treatment group 2: received oral stimulation only
Treatment group 3: received support only
Control group: no intervention described; assumed standard care
Infants in treatment group 1 received 12 minutes of a clearly described oral stimulation
protocol 30 minutes before gavage feed for last 14 consecutive days of period of gavage,
and oral support for 2 oral feeds a day for a maximum of 10 minutes per bottle during
the transition period. Treatment groups 2 and 3 each received only 1 component of this
programme
Outcomes All participants had a baseline sucking assessment with a pacifier and a transducer record-
ing system. Five-minute recordings were taken at 3, 7 and 14 days
Outcome measures:
• Sucking pressure
• Time (days) taken to attain exclusive oral feeding
• Number of bottle feeds per day and quantity of milk (percentage) ingested per day
Notes Adverse events were not reported.

Boiron 2007 (Continued)
Risk of bias
Random sequence generation (selection Low risk A blocked randomisation process is de-
bias) scribed: “randomisation lists were com-
puter generated with blocks of varying size”
Allocation concealment (selection bias) Unclear risk This is not described.
Blinding of participants and personnel High risk Investigators were not blinded to interven-
(performance bias) tion groups.
All outcomes
Blinding of outcome assessment (detection High risk Measures of sucking were made by investi-
bias) gators; it is unclear who decided to increase
All outcomes volume of oral feeding
Incomplete outcome data (attrition bias) Low risk All outcomes are reported. No data were
All outcomes missing.
Other bias High risk Adverse events were not reported. It is un-
clear who decided to increase volume of
oral feeding as intervention progressed
Fucile 2002
Methods Country: USA

RCT
Random sequence generation: stratified random sampling technique used to ensure
that groups were similar in mean gestational age and birth weight
Allocation concealment unclear
No blinding of personnel delivering the intervention. Researchers carried out both treat-
ment and sham treatments. Caregivers and family blinded to intervention
Blinding of outcome assessors unclear
Treatment duration: 10 consecutive days
Participants 32 participants in total: 19 females, 13 males

16 participants in each group
Treatment group: N = 16, age range 28 ± 1.3 weeks, GA 26.4 to 29.9 weeks, birth
weight 1044 ± 260 (740 to 1500) grams Control group: N = 16, age range 28.1 ± 1.1
weeks, GA 26.0 to 29.7 weeks, birth weight 959 ± 244 (560 to 1300) grams

Fucile 2002 (Continued)
Interventions Nursing and medical staff were reported to be blinded to the intervention, as a screen was
placed around the isolette during any intervention. Both groups were monitored from
time of entry into the study until discharge from the hospital. Initiation and advance-
ment of oral feeding were left to the discretion of the attending physician and nurses
who were responsible for standard feeding care. Measures were taken at the introduction
of oral feeds, at 1 oral feed per day, at 4 oral feeds per day and at 8 oral feeds per day.
Interventions were started 48 hours after discontinuation of nasal CPAP. Intervention
was not administered if infants were disturbed 30 minutes before the intervention, and it
was stopped if infants were medically unstable and/or had any episodes of oxygen desat-
uration and/or apnoea/bradycardia during the intervention. Treatment group received a
prefeeding oral stimulation programme consisting of a 12-minute finger stroking pro-
tocol, followed by 3 minutes of sucking on a pacifier. Intervention lasted 15 minutes
and was performed once a day for 10 consecutive days, 15 to 30 minutes before a tube
feeding
Control group received sham stimulation identical to the prefeeding stimulation pro-
gramme, except that they did not receive the 15-minute finger stroking and pacifier
portion of the protocol
Outcomes • Days to transition from complete tube feeding to independent oral feeds
• Days to 1 oral feed a day
• Days to 4 oral feeds a day
• % volume intake
• Rate of milk transfer (mL/min)
• Length of stay
• PMA and weight at both 1 to 2 oral feeds per day and 6 to 8 oral feeds per day
• Sucking pattern maturation
• Sucking frequency and amplitude
• Behavioural state before and after feeds, number of episodes of apnoea,
bradycardia or oxygen desaturation
Notes Both gestational age (GA) and postmenstrual age (PMA) are used in the report. GA is
used to describe age at birth and age range of groups, PMA to describe age at feeding
Some adverse effects were reported in 1 case, in which bradycardia was observed but
resolved spontaneously
Risk of bias
Random sequence generation (selection Low risk Infants were randomised into control or ex-
bias) perimental groups in blocks of 4, stratified
by gestational age (26 to 27 vs 28 to 29
weeks)
Allocation concealment (selection bias) Unclear risk This was not described.
Blinding of participants and personnel Low risk Researchers carried out both treatments
(performance bias) and sham treatments. Caregivers and fam-

All outcomes ily were blinded to intervention
Blinding of outcome assessment (detection Low risk Advancement of oral feeding was done
bias) at the discretion of physicians, who were
All outcomes blinded to treatment allocation
Incomplete outcome data (attrition bias) High risk It is reported that groups were similar
All outcomes in baseline characteristics, such as num-
ber of infants who received breast feed-
ings throughout the study, gastric residu-
als, oxygen requirement, episodes of oxygen
desaturation and/or apnoea/bradycardia at
the 3 monitored feeding sessions and be-
havioural state, although data are not pro-
vided to confirm
Selective reporting (reporting bias) High risk Not all outcomes are fully reported as
above.
Other bias Unclear risk Information provided was insufficient to

permit judgement.
Fucile 2011

RCT
Random sequence generation: infants randomised through stratified blocked randomi-
sation
Follow-up: participants monitored from study start to hospital discharge
Treatment duration: 14 days
Participants 75 infants were enrolled:

Group 1: N = 19 (12 male/7 female), 10 age 26 to 29 weeks GA, 9 age 30 to 32 weeks
GA, birth weight not provided but weight at introduction of oral feeding was 2001.3
(63.3) grams
Group 2: N = 18 (11 male/7 female), 8 were 26 to 29 weeks GA, 10 were 30 to 32 weeks
(108.7) grams
Group 3: N = 18 (10 male/8 female), 11 were 26 to 29 weeks GA, 7 were 30 to 32 weeks
(48.7) grams
Control group: N = 20 (16 male/4 female), 9 were 26 to 29 weeks GA, 11 were 30
to 32 weeks GA, birth weight not given but weight at introduction of oral feeding was
1885.2 (61.5) grams
Interventions Group 1, oral (O): twice-daily finger stroking protocol of the cheeks, lips, gums and
tongue for 12 minutes and NNS for 3 minutes as per previously described protocol
Group 2, T/K: twice-daily stroking of the head, neck, back, arms and legs for 10 minutes
and passive range of motion to the limbs for 5 minutes

Group 3, O + T/K: 15 minutes of O or T/K, each once a day, in random order

Control intervention: Researcher placed her hands in the incubator but did not touch
the infant for 15 minutes twice daily
Assigned interventions were started 48 hours after discontinuation of nasal CPAP and
were administered in two 15-minute sessions/d for 10 days over a 14-day period. Sessions
were provided 30 minutes before tube feedings, with a minimum 3-hour interval between
sessions, to clinically stable infants. Interventions were stopped if adverse effects were
observed. All interventions were administered by the same researcher. A screen was placed
around the incubator for all interventions
Data on the primary outcome were gathered from the charts of 10 additional infants to
assess for any potential Hawthorne effect (Hawthorne group)
Outcomes • Time to attainment of oral feeding

• Proficiency (% milk in first 5 minutes)
• Volume transfer (% volume consumed/total)
• Rate of transfer (mL/min)
• Volume loss, length of hospital stay
• Neurobiological risk score
• Apnoea
• Bradycardia
• Oxygen desaturation
• Fussing
• Crying
• Spitting up
• Number of infants receiving co-interventions (occupational, physical and/or
speech therapy)
• Number of parental visits
Notes Both GA and PMA were used to describe participant age.

Adverse events: Of 1100 administered interventions, 13 (1.1%) were stopped because of
apnoea, bradycardia or oxygen desaturation episodes, all of which resolved spontaneously
Risk of bias
Random sequence generation (selection Low risk Participants were randomised in blocks
bias) (size not stated) stratified by gestational age
(26 to 29 vs 30 to 32 weeks) and time (“ev-
ery 3 months”)
Blinding of participants and personnel Low risk Blinding of caregivers was attempted by
(performance bias) sham procedure (therapist placed hands
All outcomes in incubator for 15 minutes) with screen
placed around the incubator
Investigator was not blinded to the inter-
vention but was not involved in outcome

measurement
Blinding of outcome assessment (detection Low risk Primary outcome was time to indepen-
bias) dent oral feeding; feeding advancement was
All outcomes done at the discretion of blinded physicians
Incomplete outcome data (attrition bias) High risk Information was provided regarding num-
All outcomes ber of infants receiving co-interventions
(occupational, physical and/or speech ther-
apy)
Number of parental visits was not reported.
Selective reporting (reporting bias) High risk As above. Information was provided re-
garding number of infants receiving co-in-
terventions (occupational, physical and/or
speech therapy)
Number of parental visits was not reported.
Other bias Unclear risk Parental visit and therapy intervention in-
formation is required to inform interpreta-
tion of outcomes
Fucile 2012

RCT
Random sequence generation: infants randomised by stratified blocked randomisation
Allocation concealment: no
Blinding of personnel delivering the intervention: unclear
Blinding of outcome assessors: unclear
Treatment duration: 14 days
Participants 75 infants were enrolled:

Group 1, O: N = 19 (12 male/7 female), age range 29.6 weeks GA (SEM 0.4), 10 were
26 to 29 weeks GA, 9 were 30 to 32 weeks GA, birth weight 1359.7 (78.2) grams
Group 2, T/K: N = 18 (11 male/7 female), 8 were 26 to 29 weeks GA, 10 were 30 to
32 weeks GA, birth weight 1325.4 (53.3) grams
Group 3, O + T/K: N = 18 (10 male/8 female), 11 were 26 to 29 weeks GA, 7 were 30
to 32 weeks GA, birth weight 1329.6 (39.1) grams
Control group: N = 20 (16 male/4 female), 9 were 26 to 29 weeks GA, 11 were 30 to
32 weeks GA, birth weight 1346.6 (39.3) grams
Interventions Group 1, oral (O): twice-daily finger stroking protocol of the cheeks, lips, gums and
tongue for 12 minutes and NNS for 3 minutes as per previously described protocol
Group 2, T/K: twice-daily stroking of the head, neck, back, arms and legs for 10 minutes
and passive range of motion to the limbs for 5 minutes
Group 3, O + T/K: 15 minutes of O or T/K, each once a day, in random order
Control intervention: Researcher placed her hands in the incubator but did not touch
the infant for 15 minutes twice daily
Assigned interventions were started 48 hours after discontinuation of nasal CPAP and
were administered in two 15-minute sessions/d for 10 days over a 14-day period. Sessions
were provided 30 minutes before tube feedings, with a minimum 3-hour interval between
sessions, to clinically stable infants. Interventions were stopped if adverse effects were
observed
Participants were monitored from study start to hospital discharge. Nutritive sucking
skills were assessed on a 5-point stage of sucking scale, suck/swallow co-ordination was
assessed by a suck-to-swallow ratio and respiratory patterns were assessed with nipple-
bottle apparatus that simultaneously recorded suck, swallow and respiration. These mea-
surements were monitored once during 3 oral feeding sessions, when infants were taking
1 to 2, 3 to 5 and 6 to 8 oral feedings per day. Management of feeding was left to the
discretion of attending neonatologists. Nurses were responsible for standard feeding care
Outcomes • Stage of sucking

• Stage of sucking at 1 to 2 oral feeds/d
• 3 to 5 oral feeds/d
• 6 to 8 oral feeds/d
• Suction amplitude
• Expression amplitude
• Suck/swallow co-ordination
• Swallow/respiratory co-ordination
• Pause-swallow-pause (P-SW-P) patterns
• Expire-swallow-expire (E-SW-E) patterns
Also recorded were severity of illness, number of infants receiving all or partial breast feed-
ing, number of co-interventions (occupational/physical and/or speech therapy), number
of parental visits, PMA, days of life, behavioural state during feeding measured on a
3-point scale and episodes of apnoea, bradycardia and/or oxygen desaturation at the 3
monitored oral feeding sessions
Notes Adverse events were not reported although they were recorded as part of the protocol
Although not stated in the study, the profile of these study participants is the same as in
Fucile 2011.
Risk of bias
Random sequence generation (selection Unclear risk Although it was not explicitly stated, this
bias) paper appears to report secondary out-
comes for infants described in Fucile 2011,
as identical numbers of infants are reported
in each of the 4 groups. If so, infants in
Fucile 2011 were randomised in blocks
(size not stated) stratified by gestational age
(26 to 29 and 30 to 32 weeks GA) and time
(3-month intervals)

Allocation concealment (selection bias) Unclear risk This was not described, although a screen
was placed around the incubator for all in-
terventions
Blinding of participants and personnel High risk Caregivers were blinded.

(performance bias) All interventions were administered by the
All outcomes same researcher, who therefore must have
been aware of allocation
Blinding of outcome assessment (detection High risk Unblinded researcher assessed outcomes.
bias)
All outcomes
Incomplete outcome data (attrition bias) High risk Some outcomes were reported for all 75
All outcomes infants; some data were missing
Selective reporting (reporting bias) High risk All of the study’s prespecified outcomes and
all expected outcomes of interest to the
review have not been reported. The pro-
tocol specifies that the following co-vari-
ates were considered and recorded: severity
of illness, number of infants receiving all
or partial breast feeding, number of co-in-
terventions (occupational/physical and/or
speech therapy), number of parental visits,
PMA, days of life, behavioural state dur-
ing feeding measured on a 3-point scale
and episodes of apnoea, bradycardia and/
or oxygen desaturation at the 3 monitored
oral feeding sessions. No outcomes were re-
ported for these co-variates
Other bias High risk Although it was not stated in the study,
the profile of these study participants is the
same as in Fucile 2011.
Gaebler 1996

RCT
Random sequence generation: no information
Allocation concealment: no information
Blinding of personnel delivering the intervention: no
Blinding of outcome assessors: no
Participants 18 participants
Experimental group: N = 9 (6 male/3 female/9 Caucasian), mean birth age (range) 32.
3 weeks GA (30 to 34), age (range) at start of study 34.3 weeks PCA (32 to 36), mean

Gaebler 1996 (Continued)
(range) birth weight 1836 (1605 to 2282) grams

Control group: N = 9 (6 male/3 female/8 Caucasian/1 Black-Caucasion), mean birth
age (range) 32.4 weeks GA (31-34), age (range) at start of study 34.1 weeks PCA (33 to
36), mean (range) birth weight 1729 (1410 to 1975) grams
Interventions NPIA was administered within 24 hours of entry to study, between 30 and 90 minutes
before a scheduled feeding by 1 of 4 occupational or physical therapists. Recommen-
dations were made to nursing staff. Then all parents and nurses were provided with
information regarding a 5-minute stroking protocol
Parents of the experimental group were given further separate instruction about a 2-
minute oral motor protocol. They were instructed to carry it out 3 times a day, 5 days a
week, before feedings, only until infants were nipple feeding all of their feedings for 24
hours. Parents were instructed to feed infants after they had administered the prefeeding
protocol (stroking protocol or stroking, perioral and intraoral protocol). If parents were
not able to administer the protocol, nursing staff did so. R-NOMAS was administered
within 48 hours of first nipple feed, then again on the following third and fifth days.
They were discharged from the study once the infant managed all feeds orally for 24
hours
All protocols were to be carried out 5 minutes before feeding, 3 times a day for 5 days
Control group carried out a stroking protocol only, involving stroking baby in the isolette
on back of head, across neck and shoulders, down head, down legs and down arms, 5
minutes before scheduled feeding. Experimental group was instructed to do the stroking
protocol, then a 2-minute oral motor stimulation protocol. Oral stimulation protocol
was to take place outside the isolette if the infant was to be held for the feeding, otherwise
inside the isolette
Outcomes • % nipple feeds engaged in

• R-NOMAS scores at assessment 1, day 3 and day 5
• Discharge from hospital (days)
• Days in study
• Intake for first 5 minutes of nutritive sucking on third and fifth days of R-
NOMAS testing
• Between-group maturation/age
• Number of prefeeding protocols
Notes Adverse effects and unwanted symptoms were not reported.
Risk of bias
Random sequence generation (selection Unclear risk No details were provided about how infants
bias) were assigned to either group
Allocation concealment (selection bias) Unclear risk No information was provided.
Blinding of participants and personnel High risk Protocols were posted on the isolettes, so
(performance bias) therapists and nursing staff were aware of
All outcomes group assignments

Gaebler 1996 (Continued)
Blinding of outcome assessment (detection High risk Outcome assessors were 1 of the 4 re-
bias) searchers; all were aware of group assign-
All outcomes ments, as above
Incomplete outcome data (attrition bias) Low risk All outcome data were provided for all in-
All outcomes fants.
all expected outcomes of interest to the
review have been reported. No data were
missing
Other bias High risk Parents were instructed to feed infants af-
ter they had administered the prefeeding
protocol and to hold infants in a sup-
ported, flexed position for all feedings - nip-
ple or gavage - to facilitate active sucking.
This could have had an influence on abil-
ity to suck and feed, thereby introducing
bias. Additionally, both parents and nurs-
ing staff/researchers carried out the inter-
ventions, which may have added variability
in delivery of interventions
Harding 2006
Methods Country: UK
RCT
Random sequence generation using stratified random sampling technique
Allocation concealment reported
Participants 14 participants (3 male/11 female) - paired groups

Pair 1: GA 27 weeks, birth weight 1325 grams (intervention infant)/1085 grams (control
infant)
infant)
infant)
infant)
infant)
infant)
infant)

Harding 2006 (Continued)
Interventions Intervention was delivered by parents.

Experimental group: Parents provided 10 minutes of oral stimulation by gently stroking
the bottom lip with a finger or a pacifier, then moving intraorally to stimulate the tongue
with a gentle front-to-back movement until the finger/pacifier was prompting an NNS
pattern. This was carried out during the first 10 minutes of a tube feed from the time
infants demonstrated readiness to attempt oral feeding with no supplements until they
received all feeds orally
Control group: No oral stimulation protocol was followed, but infants received usual
developmental care approach from the unit, with an SLT providing verbal support and
discussion of oral feeding
Outcomes • Days taken to achieve oral feeding

• Days spent in hospital
• NOMAS scores
Notes No adverse effects were recorded or reported.
Risk of bias
Random sequence generation (selection Low risk A ’matched pairs design’ was used. Infants
bias) were matched for gestational age and as
closely as possible for birth weight. A mem-
ber of each pair was randomly allocated
to treatment or control through a strati-
fied random sampling technique. Alloca-
tion was completed by computer-generated
random number system
Blinding of participants and personnel Unclear risk Parents performed the intervention. It is
(performance bias) unclear whether parents or medical/nurs-
All outcomes ing staff were aware of group allocation
Blinding of outcome assessment (detection Unclear risk ”The assessment was conducted by the re-
bias) searcher and a speech & language therapist.
All outcomes .. who was unaware of the group allocation’
It is unclear whether the researcher and the
speech and language therapist were aware
of group assignment
Incomplete outcome data (attrition bias) Low risk Data were reported for all enrolled infants.
All outcomes

Other bias Unclear risk No adverse effects were recorded or re-

ported.
Harding 2014
Methods Country: UK
RCT
Random allocation by computer-generated distribution
Participants 59 premature infants born between 26 and 35 weeks
Interventions Parents, nursing and therapy staff completed the interventions

Parents were encouraged to implement the programme a minimum of 3 times a day
Nursing/therapy staff completed interventions if parents were unable to be present
Group 1: NNS (i.e. perioral stimulation programme, as per Fuclie et al, 2002) before
start of tube feeding
Group 2: NNS at start of tube feeding
Group 3: standard care
Outcomes • Days to full oral feeding

• Days in hospital
• Number of infants discharged home while breast feeding
• NOMAS scores
• Expressive and Receptive Language scores on Preschool Language Scales (PLS)
Notes Adverse events were not reported.

Investigators did not record how many intervention sessions were completed by parents/
nurse/therapist per participant
Risk of bias
Random sequence generation (selection Low risk Participants were randomised to 1 of 3

bias) groups by computer-generated distribution
Allocation concealment (selection bias) High risk This was a non-blinded study.
Blinding of participants and personnel High risk This was a non-blinded study. Parents and
(performance bias) therapy staff and nursing staff could all
All outcomes complete the interventions when necessary
Blinding of outcome assessment (detection High risk This was a non-blinded study.
bias)
All outcomes

Incomplete outcome data (attrition bias) Unclear risk Of 60 enrolled infants, 4 did not complete
All outcomes the study: 2 deteriorated with changes in
health and did not progress with the inter-
vention, 2 moved away from the area
No intention-to-treat analysis was com-
pleted. Acceptable reasons were provided
for missing data, and all groups were
equally balanced

judgement.
Lessen 2011

RCT
Random sequence generation: yes
Allocation concealment: unclear
Blinding of personnel delivering the intervention: unclear
Participants A total of 19 participants were included:

PIOMI (intervention) group: N = 10 (4 male/6 female), age range 28.1 ± 0.6 weeks
PMA, birth weight 1017.3 ± 127.1 grams, weight at entry to study 1.0 ± 124.6 kg
Control group: N = 9 (3 male/6 female), age range 28.0 ± 0.9 weeks PMA, birth weight
913 ± 87.8 grams, weight at entry to study 915 ± 145.2 grams
Infants were enrolled if they were born between 26 and 29 weeks PMA and were appro-
priate for gestational age, were clinically stable but could be receiving oxygen via high-
flow nasal cannula and had no comorbidities
Interventions Experimental group: received PIOMI (premature infant oral motor intervention),
which is a 5-minute oral motor programme that provides assisted movement to activate
muscle contraction and provides movement against resistance to build strength. Each
intervention was separated by a minimum of 9 hours and a maximum of 36 hours, with
24 hours being ideal
Control group: did not receive the 5-minute oral stimulation intervention. PI or RA
stood at the bedside during that time with both hands inside the isolette for 5 minutes,
not touching the infant. Intervention took place over 7 consecutive days and outcomes
were measured until discharge. Data collection began on the day the infant reached 29
weeks PMA (before oral feed commencement) and continued once a day for 7 consecutive
days, ending at 30 weeks PMA. Oral feeding trial could then commence. Intervention
was carried out before a feeding once a day for 7 consecutive days. A card on each
participant’s bed identified him/her as a participant in the study, but group assignments
were blinded to nursing and medical staff and to parents by a curtain pulled around the

Lessen 2011 (Continued)
infant’s bed for both control (sham) and intervention groups. Feeding progression was
tracked through a 6-phase feeding progression protocol. The intervention was provided
by the PI or by 1 of 3 research assistants (RAs)
Outcomes • Mean days gavage feeds to total oral feeds

• Transition time through feeding phases
• Length of stay
• Mean birth weight
• Apnoea
• Bradycardia
Notes Nine of 16 infants who received the PIOMI intervention experienced 1 to 3 mild ap-
noea/bradycardia episodes across the 7 days that were self-corrected after pausing the
intervention, and the intervention was continued with no further signs of intolerance
Risk of bias
Random sequence generation (selection High risk “All infants were randomly assigned in
bias) blocks of 2”. Possible selection bias cannot
be ruled out
Allocation concealment (selection bias) High risk Infants allocated in “blocks of 2”; there-
fore next allocation of next infant was
known. Also, “if subjects in either group
were dropped, they were replaced by assign-
ing the next enrolled subject to that group
to maintain equal numbers in groups”
Blinding of participants and personnel High risk Allocation was concealed from medical and
(performance bias) nursing staff and parents by screening re-
All outcomes searcher who performed intervention or
sham. Blinding of some key study per-
sonnel was attempted, but researcher was
not blinded to the groups; this is likely to
introduce performance bias. It is unclear
whether outcome assessor was blinded
Blinding of outcome assessment (detection Unclear risk Progression of oral feeding was determined
bias) from bedside charts, but it is unclear who
All outcomes decided on progression of oral feeds
Incomplete outcome data (attrition bias) Low risk Eleven (of 30) enrolled infants were ex-
All outcomes cluded post randomisation, and reasons
were provided

Lessen 2011 (Continued)
Selective reporting (reporting bias) Unclear risk All of the study’s prespecified outcomes and

judgement.
Lyu 2014
Methods Country: China

RCT
Participants Healthy preterm infants born between 29 and 34 weeks GA

Intervention group: N = 32 (male 16/female16), GA 30.87 ± 1.47 weeks, weight 1597.
38 ± 264.263 grams
Control group: N = 31 (16 male/15 female), GA 30.92 ± 1.48 weeks, weight 1652.50
± 327.468 grams
Interventions Oral stimulation programme was developed by Fucile (2002) and consisted of 12 minutes
of oral stimulation and 3 minutes of non-nutritive sucking
Control group received routine feeding care.
Outcomes • Oral feeding progression

• Oral feeding performance/efficiency
• Transition time to full oral feeding
• Weight gain
• Episodes of apnoea, bradycardia and/or oxygen desaturation during the oral
feeding session and behavioural state at the start of the feeding session based on the
Anderson Behavioural State Scale were recorded.
Notes Study authors also provided data on duration of parenteral feeding, although this is not
listed as an outcome measure. Ten incidents in experimental groups due to delay or
stopping halfway were recorded during the intervention process. Eight incidents were
caused by delay because infants were disturbed by a medical or nursing intervention, and
2 sessions were halted after infants suffered an episode of bradycardia, which resolved
spontaneously
Risk of bias
Random sequence generation (selection Unclear risk Infants were randomly assigned to experimental and control
bias) groups by computer-generated random number assignment.
Sample size ranged from 1 to 72 as a result of the random
number generator feature in Microsoft Excel. Infants receiving
numbers 1 to 36 were assigned to the experimental group, and
those receiving numbers 37 to 72 were assigned to the control

Lyu 2014 (Continued)
group. Selection bias may be present
Allocation concealment (selection bias) High risk The order of the allocation sequence was saved and sealed in an
envelope; researchers opened the envelope and recorded groups
when infants met the inclusion criteria and after parental in-
formed consent was obtained. Researchers were most likely
aware of group allocation
Blinding of participants and personnel High risk This was not reported.
(performance bias)
All outcomes
Blinding of outcome assessment (detection Low risk The nurse on duty, who was blind to group assignments,
bias) recorded the duration and volume of feeds in every observed
All outcomes oral feeding session
Incomplete outcome data (attrition bias) High risk Behavioural state feeding data, which were recorded at the start
All outcomes of the feeding session, were not reported
Selective reporting (reporting bias) High risk Behavioural outcome data were omitted.
Other bias Unclear risk Information was insufficient to permit judgement.
Neiva 2006
Methods Country: Brazil

RCT
Participants 95 preterm infants

Participants were divided into 3 groups. Weekly sucking evaluations (NNS and NS) were
filmed in a standardised manner (not described) as performed by the researcher. First
evaluation co-incided with first oral feeding
Control group: N = 35 (15 male/20 female), birth age 30.2 (SD 1.82) weeks GA, age
at start of study 31.4 (SD 1.5) weeks GA, birth weight 1389.1 (404.7) grams, weight at
study entry 1283 (SD 372.2) grams
Group 2 (NNS with pacifier): N = 30 (17 male/13 female), birth age 30.6 (SD 1.45)
weeks GA, age at start of study 31.7 (SD 1.2) weeks GA, birth weight 1357 (SD 324.2)
grams, weight at study entry 1294 (SD 338.5) grams
Group 3 (NNS with gloved finger): N = 30 (15 male/15 female), birth age 30.6 (SD
1.4) weeks GA, age at start of study 31.7 (SD 1.3) weeks GA, birth weight 1425 (SD
298.4) grams, weight at study entry 1330 (SD 305.4) grams
Interventions Control: assumed to be standard care

Stimulation with pacifier: orthodontic NUK pacifier used for premature infants daily,
except on weekends, for 10 minutes at the same time as gavage feeds
Stimulation with gloved finger: not described but delivered daily, except on weekends,
for 10 minutes at the same time as orogastric feeds

Neiva 2006 (Continued)
Outcomes • Easy beginning of sucking

• Labial sealing
• Sucking rhythm
• Labial, tongue and jaw co-ordination
• Stress signs
• Numbers of bursts and pauses per minute
• Mean duration of bursts and pauses
• Number of sucks per second
Notes It was difficult to interpret the data and present meaningful results
Language is a problem; study was published in English, but most likely this is not the
first language of study authors
Data were difficult to interpret. Abbreviations were unclear
Risk of bias
Random sequence generation (selection High risk Infants were “distributed in a random manner”, to ensure a
bias) balanced distribution of GA at birth and corrected GA in the 3
study groups. No other details were available
Allocation concealment (selection bias) High risk All interventions and assessments were carried out by the re-
searcher. No apparent attempts were made to conceal group al-
location
Blinding of participants and personnel High risk No reference is made to blinding of medical and nursing staff,
(performance bias) family or primary caregivers
All outcomes
Blinding of outcome assessment (detection High risk Outcome assessor (i.e. researcher) was aware of group assign-
bias) ment
All outcomes
Incomplete outcome data (attrition bias) High risk Summary statistics were provided, but it is unclear how many
All outcomes infants they describe
Selective reporting (reporting bias) Unclear risk All of the study’s prespecified outcomes and all expected out-
comes of interest to the review have been reported, but individ-
ual data are not available. Results were difficult to interpret be-
cause several abbreviations used in the tables were not explained
in the text nor in the Results section
Other bias Unclear risk Report was difficult to interpret.

Pimenta 2008

RCT
Participants 2 groups of healthy, stable, low birth weight, preterm infants were enrolled
98 were enrolled; 96 remained in the study until they reached corrected age of 6 months
Group 1 (Experimental): N = 47, GA at birth 30.5 ± 1.2 weeks, GA (range) on reaching
clinical stability 32 (28.6 to 35.5) weeks GA, birth weight 1204 ± 222 grams
Group 2 (Control): N = 49, GA at birth 30.2 ± 1.8 weeks, GA (range) on reaching
clinical stability 32.4 (27.5 to 34.4) weeks, birth weight 1125 ± 221 grams
Interventions Experimental group received a standardised sensory-motor-oral stimulation programme

and non-nutritive sucking, delivered by 3 trained SLTs. Groups were followed until 6
months corrected age
Group 1 (Experimental): finger stimulation programme and NNS with a pacifier, as
per Fucile 2002, performed once a day for 15 minutes during gavage feed for 10 days
until oral diet commenced
Group 2 (Control): sham stimulation during which the researcher stood around the
incubator for the same length of time as group 1, while infants were positioned and
gavage fed. No stimulation or pacifier was offered
Outcomes • Breast feeding rates on discharge (%)

• Breast feeding rates at 3 months
• Breast feeding rates at 6 months
• Length of stay
Notes
Risk of bias
Random sequence generation (selection Unclear risk “Infants were randomly assigned”; sequence generation was not
bias) described
Allocation concealment (selection bias) Low risk Sequentially numbered, sealed, opaque, non-translucent en-
velopes were used
Blinding of participants and personnel Low risk Double-blinding of medical staff at the neonatal intensive care
(performance bias) unit and at the outpatient ward, of nursing staff who provided
All outcomes care to the infants, of the speech therapist who assessed infant
capacity to begin sucking and of mothers was reported. Three
speech therapists who delivered intervention or sham proce-
dure to enrolled infants were not blinded to group allocation.
Therefore, some key study personnel were not blinded, but as
outcome assessors and all other personnel were blinded, non-
blinding of researchers is unlikely to introduce bias
Blinding of outcome assessment (detection Low risk A single external SLT who was double-blinded performed clin-
bias) ical assessment of ability to initiate oral feeding

Pimenta 2008 (Continued)
All outcomes
Incomplete outcome data (attrition bias) Low risk Two infants in experimental group were lost to follow-up at 6
All outcomes months
Intention-to-treat analysis was reported.
Reasons for loss to follow-up were not given.
Selective reporting (reporting bias) Unclear risk All of the study’s prespecified outcomes and all expected out-
comes of interest to the review have been reported
Other bias Unclear risk It is unclear whether other biases were present.
Rocha 2007

RCT
Participants Very low birth weight, healthy, stable preterm infants

Experimental group: N = 49, GA 30.5 ± 1.7 weeks, birth weight 1195 ± 221 grams
Control group: N = 49, GA 30.2 ± 1.8 weeks, birth weight 1125 ± 221 grams
Interventions Experimental group: received a stimulation protocol, as per Fucile 2002, plus non-
nutritive sucking that appears to last 15 minutes. Not clear when it took place and
under what conditions. It appears that this was continued until the newborn began an
exclusively oral diet - for at least 10 days
Control group: received gavage tube diet with a sham procedure for 15 minutes, but
this is not described
Outcomes • Length of stay

• Beginning of sucking
• Age at discharge
• Discharge from hospital (days)
Other outcomes reported but not addressed by study authors are days of life at introduc-
tion to oral feeds, days of life at full oral feeds, days of life at discharge, GA at introduction
to initial oral feeds, GA at introduction of full oral feeds and GA at discharge
Notes No adverse events were recorded or reported.
Risk of bias
Random sequence generation (selection Unclear risk A double-blind randomised clinical trial was performed.
bias) Randomisation was stratified on the basis of gestation age ranges
(26 to 28, 28.1 to 30, 30.1 to 32)
Newborns were randomised when they reached a full enteral
diet (i.e. 100 kcal/kg/d)

Rocha 2007 (Continued)
Allocation concealment (selection bias) Unclear risk Information was insufficient to permit judgement of ’yes’ or ’no’
Blinding of participants and personnel Unclear risk Procedures were performed by 3 SLTs, who used a previously
(performance bias) standardised method; this is not directly described, but the
All outcomes Fucile 2002 protocol is cited. Therefore, staff could not have
been blinded to group allocation. Staff members who measured
the weight of newborns were unaware of newborn group status.
Researchers had no influence on newborn hospital discharge
date. Therefore, some key study personnel were not blinded, but
as outcome assessors and some other personnel were blinded,
non-blinding of researchers is unlikely to introduce bias
Blinding of outcome assessment (detection Low risk The newborn’s capacity to begin an oral diet was clinically eval-
bias) uated 3 times a day by an external experienced SLT blinded to
All outcomes which group the child belonged
Incomplete outcome data (attrition bias) Low risk Data are reported for all participants.
All outcomes
Selective reporting (reporting bias) Low risk All of the study’s prespecified outcomes and all expected out-
comes of interest to the review have been reported
Other bias Unclear risk This is unclear.
Younesian 2015
Methods RCT
Country: Iran
Participants 20 healthy preterm neonates

Intervention group N = 10 (5 boys and 5 girls) GA 31.20 ± 0.78 weeks
Control group N = 10 (5 boys and 5 girls) GA 30.90 ± 0.73 weeks
All fed by tube
Interventions Oral sensory motor stimulation programme (15-minute stimulation programme, whose
first 12 minutes included stroking the cheeks, lips, gums and tongue, and whose last 3
minutes included the newborn sucking on an index finger of the speech therapist, who
was trained by the researchers) was given to the experimental group. This stimulation
programme replicated that described in Fucile 2002. Interventions were started before
the start of oral feeding and were applied once per day for 10 sequential days, 20 to 40
minutes before initiation of tube feeding. Control group received no stimulation except
routine nursery care
Outcomes • Time (days) to full oral feeding

• Weight gain

Younesian 2015 (Continued)
Notes Other co-variates were taken into account, including infant’s behavioural state at the
beginning and at the end of feeding time via the preterm infant’s behavioural scale, as
well as bradycardia, apnoea and oxygen desaturation throughout oral feeding
Two sessions were implemented owing to medical instability.
Two sessions were cancelled because infants had an episode of bradycardia
Risk of bias
Random sequence generation (selection Unclear risk Convenience sampling was performed; participants were ran-
bias) domly assigned by a simple randomisation method
Method was not described; therefore, information was insuffi-
cient to permit a judgement of ’adequate’ or ’inadequate’
Allocation concealment (selection bias) Unclear risk Information was insufficient to permit judgement.
Blinding of participants and personnel Unclear risk Both nurses and physicians involved in infant management were
(performance bias) blinded to group assignment, but breaking of blinding was pos-
All outcomes sible if SLT was noted to be delivering intervention to other
infants in the unit not involved in the study. The intervention
SLT was aware of intervention group assignment
Blinding of outcome assessment (detection Unclear risk Infants were weighed by the same nurse every day at 7 a.m. with-
bias) out clothes and diapers and before feeding. Practitioners who
All outcomes measured the weight of newborns were blinded to assigned group
and hospital discharge time. It was not stated who recorded time
to oral feeding and length of stay, and it is unclear whether they
were blinded to group allocation. Commencement and advance-
ment of oral feeding were assigned to the attending physician,
who was reported to be blinded to group allocation
Incomplete outcome data (attrition bias) High risk Information on infants’ behavioural state at the beginning and
All outcomes at the end of feeding time obtained via the Preterm Infants Scale
is not reported
Selective reporting (reporting bias) High risk Not all of the study’s prespecified outcomes and all expected
outcomes of interest to the review have been reported
Other bias Unclear risk Adverse events were not reported.

Zhang 2014
Methods RCT
Country: China
Randomised groups
Participants 108 preterm infants
Interventions Group 1, NNS: sucked on pacifier for 5 minutes 7 to 8 times a day

Group 2, oral stimulation (OS): 12-minute peristimulation programme, as per Fucile
2002
Group 3: combined both of the above interventions
Outcomes • Transition time to full oral feeding

• Rate of transfer (mL/min) at D1, D4, D4, DA (autonomous feeding)
• Proficiency (i.e. volume of milk taken during first 5 minutes at D1, D4, D4, DA
(autonomous feeding))
• Volume transfer (i.e. volume consumed as % of the total at D1, D4, D4, DA
(autonomous feeding))
• Length of stay
• Average weight gain (%)
• Degree of illness recorded on Neonatal Medical Index at admission to NICU
Notes Behavioural state was measured at the start of the feeding session by the Anderson
Behavioural State Scale
Episodes of apnoea, bradycardia and/or oxygen desaturation during the feeding session
were also measured
Risk of bias
Random sequence generation (selection Low risk Participants were randomised by stratified
bias) blocked randomisation
Allocation concealment (selection bias) Unclear risk Information was insufficient to permit
judgement.
Blinding of participants and personnel Unclear risk Two experienced researchers were responsi-
(performance bias) ble for administration of all interventions.
All outcomes Initiation and advancement of oral feed-
ing were left to the discretion of the physi-
cian; it is unclear whether the physician was
blinded. It is unclear whether other person-
nel (nurses, parents) were blinded to allo-
cation
Blinding of outcome assessment (detection Low risk Initiation and advancement of oral feed-
bias) ing were left to the discretion of the physi-
All outcomes cian. Feeding variables (rate of transfer/
proficiency/volume transfer at days 1, 4

Zhang 2014 (Continued)
and 7) and DA (day autonomous feeding

achieved) were monitored by a second re-
searcher, who was blinded to group alloca-
tion
Incomplete outcome data (attrition bias) High risk Study authors report, ’there was no dif-
All outcomes ference in terms of behavioural state and
numbers of episodes of apnoea, bradycar-
dia or oxygen desaturations’; however, apart
from severity of illness scores (Neonatal
Medicine Index) provided in the table of
baseline characteristics, no other data are
provided to confirm this
Behavioural state data before and after feeds
also are not reported
Selective reporting (reporting bias) High risk This is the same as above.

judgement.
CPAP: continuous positive airway pressure.

DA: day autonomous feeding achieved.
GA: gestational age.
KMC: kangaroo mother care.
NICU: neonatal intensive care unit.
NNS: non-nutritive sucking.
NPIA: Neurobehavioral Preterm Infant Assessment.
NS: nutritive sucking.
OMS: oromotor stimulation.
PCA: postconceptional age.
PI: principal investigator.
PIOMI: premature infant oral motor intervention.
PLS: Preschool Language Scales.
PMA: postmenstrual age.
RA: research assistant.
RCT: randomised controlled trial.
R-NOMAS: Revised Neonatal Oral Motor Assessment Scale.
SEM: standard error of the mean.
SLT: speech and language therapist.

Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Anderson 1986 This is a descriptive literature review of interventions only
Bache 2014 Populations described were preterm infants with respiratory distress syndrome and chronic lung disease,
making comparison with healthy preterm infants difficult.
Barlow 2008 Researchers described an adapted pulsating pacifier for patterned orocutaneous stimulation, not a finger
stimulation protocol
Barlow 2014a Outcomes were specific to non-nutritive sucking parameters only, not to feeding. The population under
investigation consists of preterm infants with respiratory distress syndrome and preterm infants of diabetic
mothers. It is difficult to compare these infants with healthy preterm infants
Barlow 2014b Populations described are preterm infants with respiratory distress syndrome and chronic lung disease,
making comparison with healthy preterm infants difficult
Bingham 2010 This was not a randomised controlled trial. It was a prospective observational study of 51 infants in various
NICUs
Bragelien 2007 Method of sucking stimulation described as the intervention was based on ’Vojta’s’ technique (i.e. initiating
reflex activity of striate and smooth muscle by stroking the chest and underneath the jaw). This was not a
finger stimulation protocol by our definition
Breton 2008 This is a review of literature and current research.
Brown 2013 This case study design did not involve oral stimulation.
Case-Smith 1988 This trial used a single-study design.
Chang 2007 Intervention described was not an oral stimulation intervention
Chorna 2014 A percentage of both intervention and control groups had ’white matter injury, all types’ and ’white matter
injury, severe’, as reported, and these participants cannot be extracted from the rest of the group. Therefore,
not all infants in both groups were ’healthy preterm infants’, and this study cannot be compared with the
other included studies, from which such infants were excluded
Christensen 1976 This study did not include premature infants and was not a randomised controlled trial
Coker-Bolt 2013 This was not a randomised controlled trial. Two groups were compared, including 1 treatment group and
1 historical group, which did not receive treatment
Collins 2004 Intervention described is not an oral stimulation intervention
Dawson 2013 No oral stimulation intervention was reported.
De Curtis 1986 This study used an inadequate design and inappropriate outcome measures

(Continued)
Dieter 1997 This study is a literature review.
Einarsson-Brackes 1994 This is not a randomised controlled trial.
Engebretson 1997 Appropriate outcome measures were not included.
Ernst 1989 Intervention involves use of pacifiers during tube feeds and did not involve a finger stimulation protocol
Faherty 2006 This is a review and discussion of the literature.
Fan 2013 This trial did not report on any of our primary or secondary outcomes
Fewtrell 2012 This trial assessed bottle design - not oral stimulation.
Field 1982 Infants were given pacifiers during all tube feeds. Study did not involve a finger stimulation programme
Finan 1996 This study described development of a piece of equipment for assessing the sucking ability of preterm
infants
Fucile 2009 A controlled flow vacuum free bottle system is not an oral stimulation intervention
Gill 1988 No relevant outcomes were measured. Behavioural state observations were reported
Gill 1992 No relevant outcomes were measured. Behavioural state observations were reported
Glass 1994 This is a review article.
Gosa 2006 This is a review and discussion of current literature.
Hill 2000 This was a cross-over trial.
Howard 2003 This study did not include preterm infants < 37 weeks.
Hwang 2010 This was not a randomised controlled trial.
Kao 2010 This study used a cross-over design.
Kumar 2010 Spoon feeding is not an oral stimulation intervention.
Lau 2000b This was not a randomised controlled trial.
Lau 2012 Intervention options involve pacifier sucking and swallowing or placing a milk bolus on the tongue, where
the bolus rests before entering the pharynx. Neither is a finger stimulation protocol by our definition
Lau 2014 This is a review and discussion of current literature.
Loewy 2013 Music therapy described involves presentation of audio only to premature infants and does not involve an
oral stimulation intervention

(Continued)
Luo 2012 The study population consisted of mechanically ventilated preterm infants, making comparison with
healthy preterm infants difficult. Additionally, outcomes did not include oral feeding, but rather time
to reach full enteral feeding, birth weight recovery time, body weight growth rate, hospitalisation time,
feeding tolerance and mechanical ventilation-related complications
Malhotra 1999 This was not a randomised controlled trial.
Mattes 1996 Intervention involved sweet tastes presented on a modified pacifier - not a finger stimulation protocol
McCain 1995 This was not a randomised controlled trial. Infants served as their own controls
McCain 2001 Intervention involved semi-demand gavage feeding with pacifier for NNS; this was already explored in a
previous Cochrane review (Watson 2015)
McCain 2002 Intervention involved semi-demand gavage feeding with pacifier for NNS; this was already explored in a
previous Cochrane review (Watson 2015)
McCain 2012 Study looked at transition from gavage to nipple feeding for preterm infants with bronchopulmonary
dysplasia, making comparison with healthy preterm infants difficult. Additionally, use of a pacifier was
not consistent for all infants and appears to have been done only to bring the baby to an alert state for
feeding trials, only if necessary; this was not an integral component of the intervention
Moyses 2013 This is a systematic review - not an RCT.
Philbin 2011 This study describes an assessment technique/process only.
Pickler 1996 This was not a randomised controlled trial.
Pickler 2004 This study used an inadequate randomised cross-over design, by which participants were their own controls
over 2 bottle feeds
Poore 2008b Intervention was the NTrainer device, which delivers digitally patterned orocutaneous stimulation via an
adapted pacifier - not a finger stimulation protocol
Poore 2009 This was not a randomised controlled trial. It was a descriptive review
Puckett 2008 This study did not test an oral stimulation intervention.
Rocha 2002 This was not a randomised controlled trial.
Ross 2008a This is a review and discussion of current literature.
Ross 2008b This is a descriptive review article.
Ross 2011 This study describes the development of an assessment protocol
Ross 2013 This is a systematic review.

(Continued)
Scheel 2005 This was not a randomised controlled trial.
Shaker 2010 This is a review and discussion of current literature.
Shaker 2013 This is a descriptive review of current literature and practice
Sheppard 2005 This is a review of current literature.
Sheppard 2007 This is a descriptive review of the literature.
Simpson 2002 Intervention described is not an oral stimulation intervention
Stade 2002 Intervention described is not an oral stimulation intervention
Standley 2000 This was not a randomised controlled trial.
Standley 2003 This was not a randomised controlled trial.
Standley 2010 Investigators used the Pacifier Activated Lullaby intervention (music activated in cot on commencement
of pacifier sucking), which does not involve a finger stimulation protocol
Standley 2012 This discussion paper reviews previously published data (Standley 2010a).
Thoyre 2012 This study did not include oral stimulation and was not a randomised controlled trial
Thukral 2012 Researchers used skin-to-skin contact - not oral stimulation
Vianna 2011 Investigators did not provide an oral stimulation intervention
White 2013 This is a review of current practice and does not involve oral stimulation
White-Traut 2002a Intervention described (ATVV) was not an oral stimulation intervention
White-Traut 2002b Intervention described (ATVV) was not an oral stimulation intervention
White-Traut 2013a This was a case study.
White-Traut 2013b This was not an RCT; it is descriptive only.
Yildiz 2011b Intervention groups included infants who were provided with pacifiers during gavage feeds, lullabies during
gavage feeds or standard gavage feed care. No finger stimulation protocols were used
Yildiz 2011a This study looks at olfaction - not an oral stimulation intervention
Zimmerman 2009 This is a general review of the literature.

ATVV: auditory, tactile, visual and vestibular intervention.
NICU: neonatal intensive care unit.
NNS: non-nutritive sucking.
RCT: randomised controlled trial.

DATA AND ANALYSES
Comparison 1. Comparison 1. Oral stimulation versus no intervention/standard care
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Days to full oral feeding 8 376 Mean Difference (IV, Random, 95% CI) -5.22 [-6.86, -3.59]
2 Weight gain 2 81 Mean Difference (IV, Fixed, 95% CI) 0.73 [-1.05, 2.51]
3 Total hospital stay (days) 7 301 Mean Difference (IV, Fixed, 95% CI) -5.26 [-7.34, -3.19]
4 Duration (days) of parenteral 1 19 Mean Difference (IV, Fixed, 95% CI) -5.30 [-9.73, -0.87]
nutrition
5 Exclusive direct breast feeding at 1 59 Risk Ratio (M-H, Fixed, 95% CI) 1.83 [0.96, 3.48]
discharge
6 Any direct breast feeding at 2 110 Risk Ratio (M-H, Random, 95% CI) 1.24 [0.58, 2.66]
discharge
Comparison 2. Comparison 2. Oral stimulation versus non-oral intervention
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Time (days) to achieve exclusive 5 256 Mean Difference (IV, Fixed, 95% CI) -9.01 [-10.30, -7.71]
oral feeding
2 Total hospital stay (days) 6 352 Mean Difference (IV, Fixed, 95% CI) -2.94 [-4.36, -1.51]
3 Duration (days) of parenteral 1 98 Mean Difference (IV, Fixed, 95% CI) -8.70 [-15.46, -1.94]
nutrition
4 Exclusive direct breast feeding at 1 196 Risk Ratio (M-H, Fixed, 95% CI) 0.96 [0.72, 1.28]
discharge

Analysis 1.1. Comparison 1 Comparison 1. Oral stimulation versus no intervention/standard care,
Outcome 1 Days to full oral feeding.
Review: Oral stimulation for promoting oral feeding in preterm infants
Comparison: 1 Comparison 1. Oral stimulation versus no intervention/standard care
Outcome: 1 Days to full oral feeding
Mean Mean
Study or subgroup Experimental Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI
Bala 2016 (1) 25 8.375 (2.375) 26 13.25 (3.5) 17.7 % -4.88 [ -6.51, -3.24 ]
Boiron 2007 (2) 32 6.6937 (1.3345) 11 11.2 (1.6) 19.8 % -4.51 [ -5.56, -3.45 ]
Gaebler 1996 (3) 9 11.22 (3.7) 9 14.22 (4.3) 10.2 % -3.00 [ -6.71, 0.71 ]
Harding 2006 (4) 7 15 (3.4701) 7 18 (4.0466) 9.6 % -3.00 [ -6.95, 0.95 ]
Harding 2014 (5) 39 18.059 (10.4869) 20 23.9 (10.5) 6.0 % -5.84 [ -11.50, -0.18 ]
Lyu 2014 32 9.56 (4.43) 31 13.19 (6.18) 13.7 % -3.63 [ -6.29, -0.97 ]
Younesian 2015 10 13.2 (4.31) 10 26.9 (4.79) 9.4 % -13.70 [ -17.69, -9.71 ]
Zhang 2014 (6) 81 9.1864 (4.2699) 27 14.6 (6.8) 13.5 % -5.41 [ -8.14, -2.69 ]
Total (95% CI) 235 141 100.0 % -5.22 [ -6.86, -3.59 ]

Heterogeneity: Tau2 = 3.24; Chi2 = 22.15, df = 7 (P = 0.002); I2 =68%
Test for overall effect: Z = 6.25 (P < 0.00001)
Test for subgroup differences: Not applicable
-20 -10 0 10 20
Favours experimental Favours control
(1) Median and range only provided. We calculated estimated mean and standard deviation from figures provided
(2) Data for 3 intervention groups combined
(3) Number of days in the study reported
(4) Median and range only provided. We calculated estimated mean and standard deviation from figures provided
(5) Data combined for 2 intervention groups/SD was calculated by authors from information provided
(6) Data combined for 3 intervention groups

Outcome 2 Weight gain.
Outcome: 2 Weight gain
Mean Mean
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI
Gaebler 1996 9 31.56 (6.6) 9 27.23 (5.7) 9.8 % 4.33 [ -1.37, 10.03 ]
Lyu 2014 32 11.39 (3.86) 31 11.05 (3.73) 90.2 % 0.34 [ -1.53, 2.21 ]
Total (95% CI) 41 40 100.0 % 0.73 [ -1.05, 2.51 ]

Heterogeneity: Chi2 = 1.70, df = 1 (P = 0.19); I2 =41%
Test for overall effect: Z = 0.80 (P = 0.42)
-100 -50 0 50 100


Outcome 3 Total hospital stay (days).
Outcome: 3 Total hospital stay (days)
Mean Mean
Gaebler 1996 9 13.78 (2.72) 9 17.67 (4.03) 42.7 % -3.89 [ -7.07, -0.71 ]
Harding 2006 (1) 7 29 (15.0291) 7 39.75 (23.4) 1.0 % -10.75 [ -31.35, 9.85 ]
Harding 2014 (2) 39 37.3836 (22.8611) 20 54.4 (28.62) 2.1 % -17.02 [ -31.47, -2.57 ]
Lessen 2011 10 45 (10.7) 9 44.4 (4.8) 8.0 % 0.60 [ -6.74, 7.94 ]
Lyu 2014 32 39.97 (14.81) 31 41.25 (16.15) 7.4 % -1.28 [ -8.94, 6.38 ]
Younesian 2015 10 27.9 (6.15) 10 38.8 (2.34) 25.9 % -10.90 [ -14.98, -6.82 ]
Zhang 2014 (3) 81 39.3012 (14.3074) 27 41.4 (12.9) 12.9 % -2.10 [ -7.88, 3.68 ]
Total (95% CI) 188 113 100.0 % -5.26 [ -7.34, -3.19 ]

-100 -50 0 50 100

(1) Mean and SD were calculated from the Median and range provided for each group

Outcome 4 Duration (days) of parenteral nutrition.
Outcome: 4 Duration (days) of parenteral nutrition
Mean Mean
Lessen 2011 10 18.1 (3.7) 9 23.4 (5.8) 100.0 % -5.30 [ -9.73, -0.87 ]
Total (95% CI) 10 9 100.0 % -5.30 [ -9.73, -0.87 ]

Heterogeneity: not applicable
-100 -50 0 50 100


Outcome 5 Exclusive direct breast feeding at discharge.
Outcome: 5 Exclusive direct breast feeding at discharge
Study or subgroup Experimental Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Harding 2014 25/39 7/20 100.0 % 1.83 [ 0.96, 3.48 ]
Total (95% CI) 39 20 100.0 % 1.83 [ 0.96, 3.48 ]

Total events: 25 (Experimental), 7 (Control)
0.01 0.1 1 10 100


Outcome 6 Any direct breast feeding at discharge.
Outcome: 6 Any direct breast feeding at discharge

M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
Bala 2016 14/25 8/26 50.7 % 1.82 [ 0.93, 3.57 ]
Harding 2014 13/39 8/20 49.3 % 0.83 [ 0.42, 1.67 ]
Total (95% CI) 64 46 100.0 % 1.24 [ 0.58, 2.66 ]

Heterogeneity: Tau2 = 0.18; Chi2 = 2.50, df = 1 (P = 0.11); I2 =60%
0.01 0.1 1 10 100


Analysis 2.1. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 1 Time
(days) to achieve exclusive oral feeding.
Comparison: 2 Comparison 2. Oral stimulation versus non-oral intervention
Outcome: 1 Time (days) to achieve exclusive oral feeding
Mean Mean
Asadollahpour 2015 (1) 21 17.4248 (8.8577) 11 24.27 (9.42) 3.7 % -6.85 [ -13.58, -0.11 ]
Fucile 2002 16 11 (4) 16 18 (7) 10.8 % -7.00 [ -10.95, -3.05 ]
Fucile 2011 (2) 55 10.8382 (5.1556) 20 20.7 (1.5) 73.3 % -9.86 [ -11.37, -8.35 ]
Lessen 2011 10 18.1 (3.7) 9 23.4 (5.8) 8.6 % -5.30 [ -9.73, -0.87 ]
Rocha 2007 49 38.5 (16.4) 49 47.2 (17.7) 3.7 % -8.70 [ -15.46, -1.94 ]
Total (95% CI) 151 105 100.0 % -9.01 [ -10.30, -7.71 ]

-20 -10 0 10 20
(1) Data for two intervention groups were combined
(2) Data for three intervention groups combined

Analysis 2.2. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 2 Total
hospital stay (days).
Outcome: 2 Total hospital stay (days)
Mean Mean
Asadollahpour 2015 (1) 21 27.0448 (12.2177) 11 33.45 (13.46) 2.2 % -6.41 [ -15.92, 3.11 ]
Fucile 2002 16 65 (16) 16 70 (22) 1.1 % -5.00 [ -18.33, 8.33 ]
Fucile 2011 55 53.1382 (4.0628) 20 55.3 (2.6) 82.4 % -2.16 [ -3.73, -0.60 ]
Lessen 2011 10 41.8 (7.2) 9 44.4 (4.8) 6.8 % -2.60 [ -8.05, 2.85 ]
Pimenta 2008 47 41.81 (17.7) 49 52.37 (19.51) 3.6 % -10.56 [ -18.01, -3.11 ]
Rocha 2007 49 41.9 (17.4) 49 52.3 (19.5) 3.8 % -10.40 [ -17.72, -3.08 ]
Total (95% CI) 198 154 100.0 % -2.94 [ -4.36, -1.51 ]

-100 -50 0 50 100

(1) Data for two intervention groups combined

Analysis 2.3. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 3
Duration (days) of parenteral nutrition.
Outcome: 3 Duration (days) of parenteral nutrition
Mean Mean
Rocha 2007 (1) 49 38.5 (16.4) 49 47.2 (17.7) 100.0 % -8.70 [ -15.46, -1.94 ]
Total (95% CI) 49 49 100.0 % -8.70 [ -15.46, -1.94 ]

-100 -50 0 50 100

(1) Reports days of life at full oral feeding (independent oral diet)
Analysis 2.4. Comparison 2 Comparison 2. Oral stimulation versus non-oral intervention, Outcome 4
Exclusive direct breast feeding at discharge.
Outcome: 4 Exclusive direct breast feeding at discharge

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Pimenta 2008 47/98 49/98 100.0 % 0.96 [ 0.72, 1.28 ]
Total (95% CI) 98 98 100.0 % 0.96 [ 0.72, 1.28 ]

0.01 0.1 1 10 100


ADDITIONAL TABLES
Table 1. Comparison groups: RCT allocation
RCTs in Comparison group 1 RCTs in Comparison group 2
Bala 2016 Asadollahpour 2015

Boiron 2007 Fucile 2002
Gaebler 1996 Fucile 2011
Harding 2006 Fucile 2012
Harding 2014 Lessen 2011
Lyu 2014 Pimenta 2008
Neiva 2006 Rocha 2007
Younesian 2015
Zhang 2014
APPENDICES
Appendix 1. Database search strategy

We used the search strategy recommended by the Cochrane Neonatal Review Group to find relevant studies for the review (http://
www.neonatal.cochrane.org/en/index.html). We will use search terms and synonyms for ’oral stimulation’, ’preterm infants’ and filters
to include clinical trials. We searched each database from inception to June 2013. We will search the following databases with specific
search terms as outlined below:
ERIC, PsycINFO, PsycARTICLES, ASSIA, Linguistic and Language Behaviour Abstracts via CSA:
DE=( oral or stimulation or sucking) or DE=(feeding) or (pacifier) or (oral motor) or KW=(oromotor) or (enteral nutrition) or
(parenteral nutrition) or DE=(motor manipulation) or (programme) or (myofunctional therapy) and KW=(premature or infant or
neonate) or KW=(NICU) or (Intensive Care) or (low birthweight) DE = descriptors KW = Keywords
Academic Search Complete, CINAHL Plus, AMED, UK/EIRE Reference Centre via EBSCO:
AB Oral motor or SU feeding or SU sucking or SU pacifier or SU stimulation or SU mouth or SU rehabilitation or SU treatment or
SU programme or SU oromotor AND SU neonatal or Su preterm infants or SU intensive care unit and SU Clinical trials
Science Direct and SCOPUS:
Oral stimulation OR feeding OR sucking OR oral motor exercises OR pacifiers OR stimulation OR treatment OR manipulation OR
enteral feeding OR parenteral feeding AND premature infants OR neonate OR neonatal intensive care units OR health care costs
Social Science Citation Index via ISI Web of Science:
Topic=(oral) OR Topic=(stimulation) OR Topic=(feeding) OR Topic=(sucking) OR Topic=(pacifiers) OR Topic=(programme) OR
Topic=(oral motor) OR Topic=(oromotor) OR Topic=(orofacial myology) OR Topic=(treatment) AND Topic=(preterm infant) OR
Topic=(newborn infant) OR Topic=(neonate) OR Topic=(very low birth weight) OR Topic=(neonatal intensive care unit) Refined by:
Subject Areas=(NEUROSCIENCES & NEUROLOGY) AND General Categories=(SOCIAL SCIENCES)
Highwire (Stanford University, http://highwire.stanford.edu/)
using the following key words; sucking stimulation, pacifiers, preterm, neonates, oral motor stimulation, feeding, neonatal intensive
care,
REHABDATA (http://www.naric.com/research/rehab/)
using the following free text terms; oral stimulation, oral motor, feeding, sucking, infants, training programs, programs, rehabilitation,
intervention, intensive care unit.
Searching other resources
We checked published conference proceedings of the following organisations:
• American Academy of Pediatrics.
• American Society for Parenteral and Enteral Nutrition.
• American Speech-Hearing-Language Association.
• British Association of Perinatal Medicine.
• Canadian Pediatric Society.
• Dysphagia Research Society (1992 to 2016).
• European Academy of Paediatrics.
• European Society for Paediatric Research.
• Neonatal Nurses Association.
• Royal College of Speech and Language Therapists (1999 to 2016).
• The Neonatal Society.
• Conference on Feeding and Eating in Infancy and Early Childhood (2010 to 2012).
• Personal communication with other relevant groups will be considered if appropriate.
Appendix 2. Standard search methods

PubMed: ((infant, newborn[MeSH] OR newborn OR neonate OR neonatal OR premature OR low birth weight OR VLBW OR LBW
or infan* or neonat*) AND (randomized controlled trial [pt] OR controlled clinical trial [pt] OR Clinical Trial[ptyp] OR randomized
[tiab] OR placebo [tiab] OR clinical trials as topic [mesh: noexp] OR randomly [tiab] OR trial [ti] OR comparative study) NOT
(animals [mh] NOT humans [mh]))
Embase: (infant, newborn or newborn or neonate or neonatal or premature or very low birth weight or low birth weight or VLBW or
LBW or Newborn or infan* or neonat*) AND (human not animal) AND (randomized controlled trial or controlled clinical trial or
randomized or placebo or clinical trials as topic or randomly or trial or clinical trial)
CINAHL: (infant, newborn OR newborn OR neonate OR neonatal OR premature OR low birth weight OR VLBW OR LBW or
Newborn or infan* or neonat*) AND (randomized controlled trial OR controlled clinical trial OR randomized OR placebo OR clinical
trials as topic OR randomly OR trial OR PT clinical trial)
The Cochrane Library: (infant or newborn or neonate or neonatal or premature or very low birth weight or low birth weight or VLBW
or LBW)
WHAT’S NEW
Date Event Description
6 February 2017 Amended Added external source of support
CONTRIBUTIONS OF AUTHORS
All review authors contributed to the development of this review.

DECLARATIONS OF INTEREST
Review authors have declared no conflicts of interest.
SOURCES OF SUPPORT
Internal sources
• No sources of support supplied
External sources
• Health Research Board Cochrane Training Fellowship, Ireland.
• Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health,
Department of Health and Human Services, USA.
Editorial support of the Cochrane Neonatal Review Group has been supported with federal funds from the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human
Services, USA, under Contract No. HHSN275201100016C
• National Institute for Health Research, UK.
Editorial support for Cochrane Neonatal has been funded with funds from a UK National Institute of Health Research Grant
(NIHR) Cochrane Programme Grant (13/89/12). The views expressed in this publication are those of the authors and not necessarily
those of the NHS, the NIHR, or the UK Department of Health.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

The protocol and the review differ in the following ways.
• The title of the review has changed from ’Effects of oral stimulation for oral feeding in preterm infants’ to ’Oral stimulation for
promoting oral feeding in preterm infants’.
• Review authors have redefined ’oral stimulation intervention’ to provide a specific focus and to narrow the remit of the review
for clearer reporting. Initial searching under the original definition (Greene 2012) resulted in an extremely heterogeneous group of
studies describing a wide spectrum of incomparable interventions including semi-demand gavage feeding, use of a pacifier with
gavage feeds/direct active stimulation with pacifier, finger stimulation protocols before feeds (gavage or oral) with or without other
supports, a device delivering timed electronic pulses via a nipple before feeds, body stroking protocols with or without oral
stimulation, listening to music and sucking on a pacifier before feeds and sweet tastes on a pacifier with gavage feeds. Consultation
among the Cochrane Neonatal Review Group Editors and the review authors resulted in agreement on narrowing the focus of this
review to include only studies that described a ’finger stimulation’ intervention. Additionally, several subsequent Cochrane reviews
have addressed some of these interventions, for example, non-nutritive sucking (Pinelli 2005) and semi-demand feeding (Watson
2015), so these data have been examined elsewhere. Therefore, this current review has a narrower focus, and the definition of oral
stimulation has been refined to reflect this change.
• We have excluded preterm populations with defined respiratory disease. We identified in our search several studies involving
preterm populations with defined respiratory disease. We agreed to exclude these participants, as this group is at increased risk of
feeding and swallowing problems. We had not directly specified in the original protocol that we would exclude them. We believe that
making comparisons between this group and healthy preterm infants would be difficult.
• We added methods and a plan for Summary of findings tables and GRADE recommendations; these were not included in the
original protocol.


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Cochrane Database of Systematic Reviews

Oral stimulation for promoting oral feeding in preterm infants

Greene Z, O’Donnell CPF, Walshe M

Greene Z, O’Donnell CPF, Walshe M.

Oral stimulation for promoting oral feeding in preterm infants (Review)

Oral stimulation for promoting oral feeding in preterm infants (Review) i

Oral stimulation for promoting oral feeding in preterm infants

Zelda Greene1 , Colm PF O’Donnell2 , Margaret Walshe3

Editorial group: Cochrane Neonatal Group.

To conduct subgroup analyses for the following prespecified subgroups.

• Very preterm infants born from 28 to < 32 weeks’ PMA.

• Infants bottle-fed exclusively.

PLAIN LANGUAGE SUMMARY

Oral stimulation for promoting oral feeding in preterm infants (Review) 3

Patient or population: preterm inf ants

Risk with standard care Risk with oral stimula-

Weight gain M ean weight gain: 0 M ean weight gain in the - 81 ⊕⊕

Duration (days) of par- M ean duration (days) of M ean duration (days) of - 19 ⊕

GRADE Working Group grades of evidence

Oral stimulation for promoting oral feeding in preterm infants (Review) 6

Oral stimulation for promoting oral feeding in preterm infants (Review) 7

METHODS Types of outcome measures

Types of studies Primary outcomes

Oral stimulation for promoting oral feeding in preterm infants (Review) 8

Oral stimulation for promoting oral feeding in preterm infants (Review) 9

Oral stimulation for promoting oral feeding in preterm infants (Review) 10

Oral stimulation for promoting oral feeding in preterm infants (Review) 11

Assessment of heterogeneity Subgroup analysis and investigation of heterogeneity

Oral stimulation for promoting oral feeding in preterm infants (Review) 12

Oral stimulation for promoting oral feeding in preterm infants (Review) 13

Oral stimulation for promoting oral feeding in preterm infants (Review) 14

Interventions in other trials Risk of bias in included studies

Oral stimulation for promoting oral feeding in preterm infants (Review) 15

Incomplete outcome data Comparison group 1

Figure 3. Comparison group 1. Analysis 1.1. Days to full oral feeding.

Oral stimulation for promoting oral feeding in preterm infants (Review) 16

Figure 4. Comparison group 1. Analysis 1.3. Total hospital stay (days).

Meta-analysis showed that the intervention group had a statis-

Duration of parenteral nutrition (days)

Figure 5. Comparison group 1. Analysis 1.4. Duration (days) of parenteral nutrition.

Oral stimulation for promoting oral feeding in preterm infants (Review) 17

Meta-analysis showed a statistically significant reduction in days

Oral stimulation for promoting oral feeding in preterm infants (Review) 18

Meta-analysis showed a statistically significant reduction in total

Duration (days) parenteral nutrition

Figure 8. Comparison group 2. Analysis 2.3. Duration (days) of parenteral nutrition.

Rocha 2007 showed a statistically significantly shorter duration of

Weight gain Head circumference growth

Oral stimulation for promoting oral feeding in preterm infants (Review) 20

Patient or population: preterm inf ants

Risk with non- oral in- Risk with oral stimula-

GRADE Working Group grades of evidence

Overall completeness and applicability of AUTHORS’ CONCLUSIONS

Oral stimulation for promoting oral feeding in preterm infants (Review) 23

• use a reliable of method of randomisation;

Oral stimulation for promoting oral feeding in preterm infants (Review) 30

Oral stimulation for promoting oral feeding in preterm infants (Review) 31

Characteristics of included studies [ordered by study ID]

Methods Country: Iran

Outcomes Primary outcome: time to attain independent oral feeding