Effect of Early Limited Formula on Duration and Exclusivity of Breastfeeding in

At-Risk Infants: An RCT

Valerie J. Flaherman, Janelle Aby, Anthony E. Burgos, Kathryn A. Lee, Michael D.
Cabana and Thomas B. Newman
Pediatrics 2013;131;1059; originally published online May 13, 2013;
DOI: 10.1542/peds.2012-2809

The online version of this article, along with updated information and services, is
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 ARTICLE

Effect of Early Limited Formula on Duration and

Exclusivity of Breastfeeding in At-Risk Infants: An RCT
AUTHORS: Valerie J. Flaherman, MD, MPH,a,b Janelle Aby, WHAT’S KNOWN ON THIS SUBJECT: Public health policy focuses
MD,c Anthony E. Burgos, MD, MPH,d Kathryn A. Lee, RN, on reducing formula use for breastfed infants during the birth
PhD,e Michael D. Cabana, MD, MPH,a,b and Thomas B. hospitalization. Observational evidence supports this approach,
Newman, MD, MPHa,b but no previous studies have examined the effect of early use of
Departments of aPediatrics, bEpidemiology and Biostatistics, small volumes of formula on eventual breastfeeding duration.
School of Medicine, and eFamily and Community Nursing, School
of Nursing, University of California, San Francisco, California;
c Department of Pediatrics, Stanford University, Stanford,
WHAT THIS STUDY ADDS: Use of limited volumes of formula
California; and dDepartment of Pediatrics, Kaiser Permanente during the birth hospitalization may improve breastfeeding
Medical Center, Downey, California duration for newborns with high early weight loss. Reducing
KEY WORDS the use of formula during the birth hospitalization could be
breastfeeding, lactation, infant formula detrimental for some subpopulations of healthy term newborns.
ABBREVIATIONS
CI—confidence interval
ELF—early limited formula
Dr Flaherman conceptualized and designed this study, obtained
funding, oversaw all aspects of the data collection and analysis,
and drafted the initial manuscript; Dr Aby contributed to the
abstract
study design, assisted in designing the data collection BACKGROUND AND OBJECTIVES: Recent public health efforts focus on
instruments, coordinated and supervised data collection at 1 of reducing formula use for breastfed infants during the birth hospital-
the 2 data collection sites, and critically revised the manuscript
for important scientific content; Dr Burgos contributed to the
ization. No previous randomized trials report the effects of brief early
study design, coordinated data collection at 1 of the 2 data formula use. The objective of the study was to determine if small
collection sites, and critically revised the manuscript for formula volumes before the onset of mature milk production might
important scientific content; Dr Lee contributed to the study
reduce formula use at 1 week and improve breastfeeding at 3 months
design, participated in data analysis, and critically revised the
manuscript for important scientific content; Drs Cabana and for newborns at risk for breastfeeding problems.
Newman contributed to the study design, participated in METHODS: We randomly assigned 40 exclusively breastfeeding term
participant enrollment at 1 of the 2 study sites, and critically
revised the manuscript for important scientific content; and all infants, 24 to 48 hours old, who had lost $5% birth weight to early
authors approved this manuscript as submitted. limited formula (ELF) intervention (10 mL formula by syringe after
This trial has been registered at www.clinicaltrials.gov each breastfeeding and discontinued when mature milk production
(identifier NCT00952328). began) or control (continued exclusive breastfeeding). Our outcomes
www.pediatrics.org/cgi/doi/10.1542/peds.2012-2809 were breastfeeding and formula use at 1 week and 1, 2, and 3 months.
doi:10.1542/peds.2012-2809 RESULTS: Among infants randomly assigned to ELF during the birth
Accepted for publication Feb 8, 2013 hospitalization, 2 (10%) of 20 used formula at 1 week of age, compared
Address correspondence to Valerie Flaherman, MD, MPH, with 9 (47%) of 19 control infants assigned during the birth hospital-
Department of Pediatrics, University of California, San Francisco, ization to continue exclusive breastfeeding (P = .01). At 3 months, 15
3333 California St, Box 0503, San Francisco, CA 94143-0503. E-mail:
flahermanv@peds.ucsf.edu (79%) of 19 infants assigned to ELF during the birth hospitalization
(Continued on last page)
were breastfeeding exclusively, compared with 8 (42%) of 19 controls
(P = .02).
CONCLUSIONS: Early limited formula may reduce longer-term formula
use at 1 week and increase breastfeeding at 3 months for some infants.
ELF may be a successful temporary coping strategy for mothers to
support breastfeeding newborns with early weight loss. ELF has the
potential for increasing rates of longer-term breastfeeding without
supplementation based on findings from this RCT. Pediatrics
2013;131:1059–1065

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Because breastfeeding reduces the risk of discontinuation for some mothers by health benefit for some newborns if it
the most common infectious and allergic ameliorating milk supply concern. A prolonged total breastfeeding duration
diseases in infancy1–3 and because longer volume of 10 mL after each breast- and permitted an overall longer dura-
duration of breastfeeding is associated feeding was chosen for study because tion of breastfeeding without formula.
with greater health benefits,1 the World this volume would not interfere with Our group hypothesized that early limited
Health Organization,4 the Centers for breastfeeding 8 to 12 times per day as formula might be most effective among
Disease Control and Prevention,5 and the recommended.4,6,21 infants who were at higher risk of even-
American Academy of Pediatrics6 rec- This early, limited formula (ELF) ap- tual formula supplementation. In a ret-
ommend breastfeeding for at least 1 year proach is controversial for 2 reasons. rospective cohort study, we found that
and exclusive breastfeeding for at least 6 First, studies have shown that mothers newborns who lost $5% of their birth
months. Currently, public health efforts to who feed their infants both by breast weight in the first 36 hours are at in-
improve breastfeeding duration in the and with formula during the birth hos- creased risk of developing excess weight
United States include a strong emphasis pitalization discontinue breastfeeding loss of $10% of their birth weight and
on reducing the use of formula during the earlier than mothers who breastfeed may therefore be at increased risk of
birth hospitalization. The Baby Friendly exclusively during the birth hospitaliza- maternal milk supply concern.28 We un-
Hospital Initiative4 and the Joint Com- tion.22–25 However, these studies have dertook a randomized controlled trial to
mission’s Perinatal Care Core Quality been observational and might have been determine the effect of a small amount of
Measures7–10 both encourage eliminating confounded by weak prenatal intention formula delivered for a limited time on
formula use during the birth hospitali- to breastfeed. Similarly, mothers who the outcome of breastfeeding duration
zation for healthy breastfeeding infants. experience problems with initiating for newborns with $5% weight loss at
However, although 74% of US infants ini- breastfeeding, such as poor latch, de- ,36 hours. To avoid exposing newborns
tiate breastfeeding, only 30% maintain layed onset of mature milk production, to intact cow’s milk protein, we chose an
exclusive breastfeeding through 3 months or nipple pain, might be more likely to extensively hydrolyzed formula.
and only 21% are still breastfeeding at use formula and less likely to continue METHODS
12 months.11,12 Optimizing clinical and breastfeeding. The 1 quasi-randomized
We enrolled healthy, exclusively breast-
public health approaches to improving trial in this area found no benefit to
feeding term ($37 week) infants born
breastfeeding duration in the United breastfeeding duration from a hospital
at the University of California San
States might have a large beneficial policy restricting the use of formula
Francisco Medical Center and Lucille
effect on infant and maternal health. during the birth hospitalization.26
Packard Children’s Hospital who had
At birth, mothers do not immediately The second reason the ELF approach lost $5% of their birth weight before
produce copious volumes of mature may be controversial is that the in- 36 hours of age and were 24 to 48
milk, but instead begin with the se- troduction of even small volumes of hours old at enrollment. Infants were
cretion of 1 to 5 mL of colostrum per early formula might reduce some of the excluded if they had lost $10% of their
feeding.13,14 Although providers may health benefits of exclusive breast- birth weight, had received formula or
reassure mothers that these small feeding. No studies have compared the water, required a higher level of care
volumes are normal, mothers may note health outcomes associated with brief than a Level 1 nursery or had mothers
that infants appear fussy and hungry. early formula use followed by re- who were ,18 years old, could not
In combination with the observed small sumption of exclusive breastfeeding to speak English or Spanish, or were
volumes of colostrum, mothers may the health outcomes associated with making mature milk as assessed by
begin to develop a concern that their exclusive breastfeeding from birth. a previously validated technique.29
milk supply is insufficient,15 and this A recent systematic review by the Infants were weighed per hospital
concern has been demonstrated to be Cochrane collaboration found no pre- routine rather than for the purpose of
the most common reason given by vious studies examining the effect of study enrollment. Informed consent
mothers for discontinuing breastfeed- using small amounts of formula for was obtained from all mothers by
ing before 3 months.16–20 Our group a limited time on eventual breastfeed- a study doctor or nurse. This study was
hypothesized that adding the early use ing duration or other health out- approved by the University of California
of limited volumes of formula in addi- comes.27 Even if brief early formula use San Francisco Committee on Human
tion to breastfeeding before the onset reduced some of the health benefits of Research and the Stanford University
of mature milk production would have exclusive breastfeeding, brief early Administrative Panel on Human Sub-
high potential for reducing breastfeeding formula use might still have an overall jects in Medical Research.

1060 FLAHERMAN et al
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 ARTICLE

We randomly assigned 40 mother-infant Scale—Short Form30 and maternal pain of the baseline cohort were also similar
pairs either to receive limited amounts using a modified Holdcroft scale.31 Sub- between groups (Table 1).
of formula after each breastfeeding sequently, infants received usual care As seen in Table 2, breastfeeding self-
(intervention) or to continue exclusive from their individual physicians. To as- efficacy and maternal pain did not dif-
breastfeeding (control). This trial was sess compliance with assigned ran- fer by study group. Lactogenesis II
registered at clinicaltrials.gov, identifier domization group, and assess when occurred at a mean of 3.1 6 1.2 days in
NCT00952328. Thesample sizewaschosen mature milk production began, a re- both groups. At their nadir, the infants’
as a pilot to demonstrate feasibility. The search assistant called mothers daily mean weight loss was 6.8% 6 1.5% in
allocation sequence for randomization using a previously validated technique.29 the ELF group and 8.1% 6 2.3% in the
was generated by an independent bio- A research assistant blinded to group control group (P = .10). Five cohort
statistician stratified on location; assign- allocation assessed outcomes by tele- infants lost $10% of their birth weight,
ments were placed into sealed opaque phone at 1 week and 1, 2, and 3 months. including 1 (5%) of 20 in the ELF group
envelopes by an independent adminis- Our primary outcomes was formula use and 4 (21%) of 19 in the control group
trative assistant. Immediately after en- at 1 week. Our secondary outcomes in- (P = .15). One control infant had missing
rollment, a study investigator opened the cluded breastfeeding and exclusive data.
sequential envelope in the presence of breastfeeding prevalence at 1 week and 1, At 1-week assessment, all 39 infants
a second investigator and revealed the 2, and 3 months. with follow-up were still breastfeeding.
randomization arm. A blinded research However, in the ELF group, 2 (10%) of 20
assistant assessed outcomes at 1 week Using an intent-to-treat approach, we
used x2 testing to compare the effect of infants had received formula in the
and 1, 2, and 3 months. Thus we had preceding 24 hours, compared with 9
complete allocation concealment and randomization arm on dichotomous
outcomes, including breastfeeding and (47%) of 19 infants in the control group
blinded outcome assessment, although (risk difference 37%, 95% CI 3.4%–
blinding of the mother and the enrolling exclusive breastfeeding at 1 week and at
3 months. We used Student’s t test to 71.0%; P = .01). During the first week
study investigators was not possible. after birth, newborns assigned to ELF
compare the effect of group assignment
Immediately after enrollment, all received 116 6 110 mL formula, and
on infant weight and breastfeeding self-
mothers breastfed with support from controls received 262 6 411 mL. Lon-
efficacy and to compare infant age at
a study doctor or nurse. After this ger time until onset of lactogenesis II
onset of mature milk production by ex-
breastfeeding, mothers randomly as- was associated with increased likeli-
clusive breastfeeding at 3 months. For
signed to ELF (intervention group) hood of use of formula at 1 week, with
infants whose mothers had delayed on-
were taught to feed their infants 10 mL an odds ratio for formula use at 1 week
set of mature milk production, we used
of extensively hydrolyzed formula of 2.0 (95% CI 1.02–3.88) for each ad-
StatXact (Cytel, Inc, Cambridge, MA) to
(Nutramigen, Mead Johnson, Inc., ditional day until onset of lactogenesis
calculate the exact binomial 95% confi-
Evansville, IN) using a feeding syringe. II. Eleven study infants had onset of
dence intervals (CIs) for risk differences
They were instructed to syringe-feed 10 mature milk production after 72 hours
on the outcomes of exclusive breast-
mL of formula after each breastfeeding of age (delayed onset of lactation).
feeding at 1 week among infants. We
until mature milk production began. Among these 11 infants, 5 (83%) of 6
After the supervised breastfeeding, used Stata 9.2 (Stata Corp, College Sta-
randomly assigned during the birth
mothers randomly assigned to continue tion, TX) for all other analyses.
hospitalization to continue exclusive
exclusive breastfeeding (control group) breastfeeding used formula at 1 week,
were taught infant soothing techniques RESULTS compared with 1 (20%) of 5 infants
for 15 minutes. This teaching session Overall, 20 (50%) infants were assigned to with delayed onset of lactation who had
was designed to control for the amount receive ELF and 20 (50%) infants were been randomly assigned to ELF during
of time the investigator spent with assigned to continue exclusive breast- the birth hospitalization (risk differ-
mothers in the intervention group feeding (Fig 1). At enrollment, weight loss ence 63%, 95% CI –2% to 96%; P = .06).
teaching syringe feeding. was 6.0% 6 0.9% (mean 6 SD) of birth Final outcome at 3 months was obtained
Immediately after these procedures, the weight and did not differ by randomized for 38 (95%) infants, with 2 (5%) infants
research assistant verbally adminis- group allocation. Most (62%) mothers unable to be contacted. Fifteen (79%) of
tered a questionnaire to all mothers that planned to breastfeed exclusively and 19 infants randomly assigned to ELF at
assessed breastfeeding self-efficacy us- there was no group difference. Other enrollment were breastfeeding exclu-
ing amodified Breastfeeding Self-Efficacy clinical and demographic characteristics sively at 3 months, compared with 8

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FIGURE 1
Flow diagram for randomized trial of early limited formula.

(42%) of 19 controls (P = .02). Addi- group and 3 (15%) of the infants in the astrongimpactonexclusivebreastfeeding
tionally, 18 (95%) of 19 ELF infants were control group reported a febrile illness at 3 months (Table 3). Among the 11
breastfeeding to some extent at 3 (P . .30). There were no reports of al- infants with delayed onset of lactation, 8
months, compared with 13 (68%) of 18 lergic disease among study infants. (73%) were using formula at 3 months,
infants in the control group (P = .04). Two Delayed onset of lactation did not affect compared with 7 (27%) of 26 infants who
(10%) of the infants in the intervention rates of breastfeeding at 3 months but had did not have delayed onset of lactation
(P , .01). No receipt of formula at 1 week
strongly predicted any breastfeeding and
TABLE 1 Demographic and Clinical Characteristics of the Cohort
exclusive breastfeeding at 3 months.
Characteristic Early Limited Continued Exclusive P Value
Among 11 infants who received formula at
Formula Group Breastfeeding
(Intervention) (n = 20) (Control) (n = 20) 1 week, only 2 (18%) were exclusively
Gestational age, wk, mean 6 SD 40.0 6 0.8 39.8 6 1.1 .48 breastfeeding at 3 months, whereas
Vaginal delivery, n (%) 17 (85) 17 (85) 1.0 among 26 infants who did not receive
Small-for-gestational age,a n (%) 0 (0) 0 (0) NS formula at 1 week, 21 (81%) were exclu-
Infant age at enrollment, h, mean 6 SD 39.2 6 6.1 37.6 6 6.4 .42
Infant gender, % male 9 (45) 12 (60) .34
sively breastfeeding at 3 months (P ,
Maternal age, y, mean 6 SD 31.1 6 5.3 32.5 6 8.0 .51 .001).
Maternal race-ethnicity, n (%)
White Hispanic 5 (20) 9 (45) .19 DISCUSSION
White non-Hispanic 7 (35) 5 (25) .49
Asian 7 (35) 6 (30) .74 In this randomized trial, newborns with
Black non-Hispanic 1 (5) 0 (0) .31 $5% early weight loss who received
College graduate, n (%) 12 (60) 11 (55) .75
Multiparous, n (%) 14 (70) 10 (50) .20
small amounts of formula beginning at
Income .$50 000/y, n (%) 7 (35) 11 (55) .20 24 to 48 hours and ending at onset of
Percent weight loss at enrollment, mean 6 SD 6.2 6 1.0 5.8 6 0.7 .13 mature milk production (ELF group)
Plan to use formula,b n (%) 7 (47) 6 (32) .37
were more likely to be breastfeeding
NS, not significant.
a Defined as ,10th percentile for gestational age according to World Health Organization Growth Charts. and to be breastfeeding without for-
b Available for 34 subjects. mula at 3 months than controls who

1062 FLAHERMAN et al
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 ARTICLE

TABLE 2 Breastfeeding Prevalence and Related Outcomes by Randomization Arm Our findings contrast with existing re-
Outcome Early Limited Continued Exclusive P Value search in this area, which has demon-
Formula Group Breastfeeding strated that use of formula for breastfed
(Intervention) (n = 20) (Control) (n = 20)
newborns during the birth hospitali-
Modified breastfeeding self-efficacy score 3.6 6 0.6 3.5 6 0.8 .50
immediately after initial intervention,
zation is associated with shorter
mean 6 SDa breastfeeding duration.22–25 There are 2
Infant age at onset of mature milk production, 3.1 6 1.0 3.1 6 1.5 1.00 reasons why our results may differ from
d, mean 6 SD
Weight loss at nadir, % birth weight, mean 6 SD 6.8 6 1.5 8.1 6 2.3 .10
previous work. First, our intervention
Excess weight loss, $10% of birth weight, n (%) 1 (5) 4 (20) .15 incorporated 3 key structured techni-
Modified breastfeeding self-efficacy score at 1 wk, 4.0 6 0.7 3.9 6 0.7 .84 ques to reduce any negative impact of
mean 6 SD
formula on breastfeeding: (1) using
Exclusive breastfeeding at 1 wk,b n (%) 18 (90) 10 (53) .01
Breastfeeding at 1 mo,b n (%) 20 (100) 16 (84) .06 small, carefully measured volumes of
Exclusive breastfeeding at 1 mo,b n (%) 14 (70) 8 (42) .08 formula, so an infant would not be
Breastfeeding at 2 mo,c n (%) 19 (95) 14 (82) .22
satiated and demand for breastfeeding
Exclusive breastfeeding at 2 mo,c n (%) 16 (80) 8 (47) .04
Breastfeeding at 3 mo,d n (%) 18 (95) 13 (68) .04 would be maintained; (2) using a syringe
Exclusive breastfeeding at 3 mo,d n (%) 15 (79) 8 (42) .02 to prevent the nipple confusion that is
a Items rated on a scale from 1 (“Strongly Disagree”) to 5 (“Strongly Agree”), with positive scores associated with increased
associated with a bottle’s nipple; and (3)
breastfeeding self-efficacy.
b Available for 39 infants. establishing a clear time frame for ter-
c Available for 37 infants.
minating formula use. Thus, the effect
d Available for 38 infants.
of our intervention might differ from
that of unstructured formula supple-
were instructed at 24 to 48 hours rates at 3 months. Contrary to the
mentation using a bottle. Second, our
to breastfeed exclusively. Our inter- current public health emphasis on re-
randomized study design differs from
vention set clear boundaries for the ducing formula use during the birth
previous study results based on obser-
duration of supplementation by dis- hospitalization, our results suggest
continuing formula at the onset of that early supplementation of limited vational evidence, which might have re-
mature milk production. This approach volumes of formula before mature milk sidual confounding both from maternal
resulted in less formula use at 1 week production may help support long- intention to breastfeed and from early
of age, which may have resulted in the term breastfeeding for infants with difficulty establishing breastfeeding. A
observed improvement in breastfeeding early weight loss. previous cluster-randomized trial found
that formula restriction in conjunction
TABLE 3 Demographic and Clinical Factors: Association With Exclusive Breastfeeding at 3 mo with 9 other areas of change in breast-
Clinical and Demographic Factors Exclusive Using Formula P Value feeding management improved breast-
Breastfeeding at at 3 mo (n = 15) feeding rates.2 However, the design of
3 mo (n = 23) that study did not allow the authors to
Gestational age, wk, mean 6 SD 40.1 6 0.8 39.5 6 1.2 .09 report the randomized effect of formula
Infant age at enrollment, h, mean 6 SD 39.1 6 7 37.5 6 5 .45
Infant gender, % male 13 (57) 7 (47) .55
restriction alone,27 and they recently
Maternal age, y, mean 6 SD 32.0 6 5.3 31.2 6 8.6 .71 published a new analysis identifying re-
Multiparous, n (%) 18 (78) 5 (33) .006 sidual confounding in their data if ana-
Maternal race-ethnicity, n (%)
lyzed using a per-protocol approach.32
White Hispanic 8 (35) 6 (40) .74
White non-Hispanic 7 (30) 4 (27) .80 The ELF protocol might improve
Asian 7 (30) 5 (33) .85 breastfeeding by 1 of 2 mechanisms.
Black non-Hispanic 1 (4) 0 (0) .41
College graduate, n (%) 14 (61) 8 (53) .65 First, by improving newborn weight and
Income .$50 000/y, n (%) 9 (39) 8 (53) .39 hydration before the onset of mature
Vaginal delivery, n (%) 19 (83) 13 (87) .74 milk production, ELF may prevent for-
Percent weight loss at enrollment, 6.1 6 0.9 6.1 6 0.9 .62
mean 6 SD mula use after the onset of mature milk
Planned to give formula,a n (%) 7 (58) 5 (42) .85 production, and formula use at this
Infant age at onset of mature milk 2.6 6 0.8 3.8 6 1.5 .004 later time point might impact breast-
production, d, mean 6 SD
Excess weight loss, n (%) 1 (4) 3 (20) .12 feeding much more negatively than ELF.
Formula use at 1 wk, n (%) 2 (9) 9 (64) ,.0005 No use of formula at 1 week of age was
a Determined at enrollment, available for 34 subjects. the strongest predictor of exclusive

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breastfeeding at 3 months in this study. to breastfeed but high concern about a strong intention to breastfeed exclu-
Second, seeing a newborn with weight weight loss. ELF provides a strategy for sively or a strong intention to use for-
loss appear fussy and hungry may ex- using limited volume and duration of mula. Many mothers have a strong
acerbate maternal milk supply con- supplement. intention regarding feeding type, and the
cern, which is highly associated with Our study has some important limi- effect of ELF on the infants of such
breastfeeding discontinuation. By par- tations. First, our sample size was mothers cannot be inferred from this
tially ameliorating weight loss and small, leading to wide confidence study. Fourth, we did not include a de-
signs of fussiness and hunger, ELF may intervals and inability to do any sub- tailed assessment of all infectious and
provide mothers with a strategy to allay group analysis or multivariate re- allergic infant health outcomes. There-
their milk supply concern and continue gression. If the sample size had fore, we are unable to say whether the
with their desire to breastfeed for permitted it, adjustment for parity small volumes of formula used in ELF may
a longer duration. would have been important, because have affected later infant health out-
Our results are important because of there was a trend for higher parity in comes, and if so, whether any detri-
the current public health emphasis on the intervention group and multiparity mental effect of ELF on later infant health
reducing formula use during the birth was a strong predictor of exclusive outcomes might be counterbalanced by a
hospitalization. Some quality mea- breastfeeding at 3 months. Also, in our beneficial effect of ELF on total breast-
sures, specifically the new Joint Com- cohort, 50% of mothers were college feeding duration. Further research, in-
mission quality measure for exclusive graduates, and most were White or cluding long-term infectious and allergic
breastfeeding,7–10 could unintention- Asian. Further research is needed to outcomes, is needed to answer these
ally reduce breastfeeding duration for confirm our results in populations with important questions.
some segments of the population and increased diversity and with a sample
have a detrimental effect on maternal size large enough to allow subgroup CONCLUSIONS
and infant health outcomes. Reducing and multivariate analysis. Second, par- Our results suggest that in infants with
unstructured, unnecessary formula ticipants in our study were recruited $5% weight loss in the first 36 hours,
use during the birth hospitalization in in the San Francisco Bay Area, and supplementation with small volumes of
hospitals that currently have high rates overall breastfeeding duration was high formula in a structured manner may
of formula use would likely improve in our cohort. It is possible that our benefit exclusive breastfeeding at 1
breastfeeding duration. However, it intervention might be less effective week and 3 months. Further research is
is possible that current efforts to re- among populations in which breast- needed to confirm this in a larger and
duce formula use might have the in- feeding duration is shorter, because more diverse population, and to de-
advertent effect of eliminating helpful mothers in populations with shorter termine whether any such reduction in
formula supplementation in hospitals average breastfeeding duration might total formula use is associated with
with low rates of unstructured, casual discontinue breastfeeding for reasons improved health outcomes. If borne out
formula supplementation. It may be different from mothers in our cohort. by future studies, ELF could be a strategy
possible to identify infants at increased Third, mothers who chose to enroll in to manage the use of infant formula in
risk of breastfeeding discontinuation our study were open to either exclusive hospital nurseries for a specific pop-
because of factors such as weight loss, breastfeeding or supplementation with ulation of infants, and at the same time,
and offer ELF as a supportive mea- formula. Therefore, our results may not increase the likelihood of longer-term
sure for mothers with high intention be generalizable to mothers with either breastfeeding without supplementation.

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PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2013 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: Dr Cabana has served as a paid consultant for the following companies: Abbott Nutrition (Abbott Park, IL), Mead-Johnson (Evansville, IN),
Nestle SA (Vevey, Switzerland), and Pfizer Consumer Products (Madison, NJ). The other authors have indicated they have no financial relationships relevant to this
article to disclose.
FUNDING: Supported by grants 5 K12 HD052 and 1K23HD059818-01A1 from the National Institute of Children Health and Human Development. Funded by National
Institutes of Health (NIH).
COMPANION PAPER: A companion to this article can be found on page 1182, and online at www.pediatrics.org/cgi/doi/10.1542/peds.2013-0635.

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Effect of Early Limited Formula on Duration and Exclusivity of Breastfeeding in
At-Risk Infants: An RCT
Valerie J. Flaherman, Janelle Aby, Anthony E. Burgos, Kathryn A. Lee, Michael D.
Cabana and Thomas B. Newman
Pediatrics 2013;131;1059; originally published online May 13, 2013;
DOI: 10.1542/peds.2012-2809
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