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Limited Amount of Formula May Facilitate Breastfeeding: Randomized, Controlled Trial to Compare Standard Clinical Practice versus Limited Supplemental Feeding

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Objectives: Breastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless, breastfeeding rates remain low despite public health efforts. Our study aims to investigate the effect of controlled limited formula usage during birth hospitalisation on breastfeeding, using the primary hypothesis that early limited formula feeds in infants with early weight loss will not adversely affect the rate of exclusive or any breastfeeding as measured at discharge, 3 and 6 months of age. Material and methods: We randomly assigned 104 healthy term infants, 24 to 48 hours old, with ≥ 5% loss of birth weight to controlled limited formula (CLF) intervention (10 ml formula by syringe after each breastfeeding, discontinued at onset of lactation) or control group (standard approach, SA). Groups were compared for demographic data and breastfeeding rates at discharge, 3 months and 6 months of age (p-values adjusted for multiple testing). Results: Fifty newborns were analysed in CLF and 50 in SA group. There were no differences in demographic data or clinical characteristics between groups. We found no evidence of difference between treatment groups in the rates of exclusive as well as any breastfeeding at discharge (p-value 0.2 and >0.99 respectively), 3 months (p-value 0.12 and 0.10) and 6 months of infants' age (p-value 0.45 and 0.34 respectively). The percentage weight loss during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in SA group, p = 0.002). Conclusion: The study shows that controlled limited formula use does not have an adverse effect on rates of breastfeeding in the short and long term. Larger studies are needed to confirm a possible potential in controlled limited formula use to support establishing breastfeeding and to help to improve the rates of breastfeeding overall. Trial registration: ISRCTN registry ISRCTN61915183.
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RESEARCH ARTICLE
Limited Amount of Formula May Facilitate
Breastfeeding: Randomized, Controlled Trial
to Compare Standard Clinical Practice versus
Limited Supplemental Feeding
Zbyněk Straňák
1,2
, Simona Feyereislova
2
*, Marcela Černá
2
, Jana Kollárová
2
,
Jaroslav Feyereisl
3
1Third Faculty of Medicine, Charles University, Prague, Czech Republic, 2Department of Neonatology,
Institute for the Care of Mother and Child, Prague, Czech Republic, 3Department of Obstetrics and
Gynecology, Institute for the Care of Mother and Child, Prague, Czech Republic
*simona.feyereislova@upmd.eu
Abstract
Objectives
Breastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless,
breastfeeding rates remain low despite public health efforts. Our study aims to investigate
the effect of controlled limited formula usage during birth hospitalisation on breastfeeding,
using the primary hypothesis that early limited formula feeds in infants with early weight loss
will not adversely affect the rate of exclusive or any breastfeeding as measured at dis-
charge, 3 and 6 months of age.
Material and Methods
We randomly assigned 104 healthy term infants, 24 to 48 hours old, with 5% loss of birth
weight to controlled limited formula (CLF) intervention (10 ml formula by syringe after each
breastfeeding, discontinued at onset of lactation) or control group (standard approach,
SA). Groups were compared for demographic data and breastfeeding rates at discharge,
3 months and 6 months of age (p-values adjusted for multiple testing).
Results
Fifty newborns were analysed in CLF and 50 in SA group. There were no differences in
demographic data or clinical characteristics between groups. We found no evidence of dif-
ference between treatment groups in the rates of exclusive as well as any breastfeeding at
discharge (p-value 0.2 and >0.99 respectively), 3 months (p-value 0.12 and 0.10) and 6
months of infantsage (p-value 0.45 and 0.34 respectively). The percentage weight loss
during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in
SA group, p = 0.002).
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 1/12
OPEN ACCESS
Citation: Straňák Z, Feyereislova S, Černá M,
Kollárová J, Feyereisl J (2016) Limited Amount of
Formula May Facilitate Breastfeeding: Randomized,
Controlled Trial to Compare Standard Clinical
Practice versus Limited Supplemental Feeding. PLoS
ONE 11(2): e0150053. doi:10.1371/journal.
pone.0150053
Editor: Patricia Wei Denning, Emory University
School of Medicine, UNITED STATES
Received: October 20, 2015
Accepted: February 9, 2016
Published: February 26, 2016
Copyright: © 2016 Straňák et al. This is an open
access article distributed under the terms of the
Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are
credited.
Data Availability Statement: The minimal dataset
necessary to replicate the findings of this study is
available in the Supporting Information files.
Additional data is available from the corresponding
author. There are no ethical or legal restrictions
imposed that would prevent the sharing of the
authorsanonymized data; the complete datatable
(PSPP format) is available upon request by
contacting the corresponding author.
Funding: This work was funded by PRVOUK32. The
Charles University Research Development Schemes
Conclusion
The study shows that controlled limited formula use does not have an adverse effect on
rates of breastfeeding in the short and long term. Larger studies are needed to confirm a
possible potential in controlled limited formula use to support establishing breastfeeding
and to help to improve the rates of breastfeeding overall.
Trial Registration
ISRCTN registry ISRCTN61915183
Introduction
Breastfeeding is considered to be the best and most cost-effective intervention in newborns in
order to reduce morbidity, improve growth and short-term as well as long-term wellbeing. The
properties of human breast milk help to facilitate developmental changes during critical peri-
ods of brain, immune system or gut development. Major organisations, including the World
Health Organisation and UNICEF, recommend exclusive breastfeeding for the first 6 months
and continued breastfeeding for 2 years or more with adequate complementary feeding [1],
as longer duration of breastfeeding has been shown to be associated with greater health
benefits [2].
Although the benefits of breastfeeding are widely acknowledged, maintaining exclusive
breastfeeding in longer-term remains to be a challenge. WHO states that globally less than 40%
of infants under six months of age are exclusively breastfed [3]. National Center for Chronic
Disease Prevention and Health Promotion stated that in 2011 although 79% of newborn
infants started to breastfeed, only 49% were breastfeeding at 6 months and 27% at 12 months
of age in the USA [4]. In Czech Republic (place of the study) the rate for exclusive breastfeeding
is even lower and recent analysis revealed no differences in breastfeeding at discharge between
Baby Friendly Initiative Hospitals and other hospitals. The Baby-Friendly Hospital Initiative
is a worldwide programme launched by WHO and UNICEF in 1991. It is a global effort to
implement practices that protect, promote and support breastfeeding and to ensure that all
maternities, whether free standing or in a hospital, become centers of breastfeeding support by
complying with specifically developed implementation guides and global criteria including 10
specific steps to support successful breastfeeding [5,6].
To enable mothers to establish and sustain exclusive breastfeeding, WHO and UNICEF sug-
gest initiation of breastfeeding within the first hour of life; breastfeeding without any additional
food or drink, not even water; breastfeeding on demand as well as avoidance of bottles, teats
and pacifiers [7]. In general public health efforts today tend to emphasise reduction in the use
of formula during the birth hospitalisation in order to improve breastfeeding rates and dura-
tion. Some published literature suggests additional formula feeds during birth hospitalisation
may be associated with earlier discontinuation of breastfeeding [8,9], others however have
shown no benefit to duration of breastfeeding from formula restricting policy during birth hos-
pitalisation [10]. Flaherman et al. performed a randomised controlled trial assigning 40 term
infants, 24 to 48 hours old, with weight loss of 5% of birth weight to early limited formula
(ELF) intervention (10 mL formula by syringe after each breastfeeding and discontinued when
mature milk production began) or control (continued exclusive breastfeeding). The study
Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 2/12
(known under the Czech acronym PRVOUK) have
been providing institutional support for research at
Charles University since 2012. The schemes are
financed from the funding received from the state
budget to support the Universitys long-term strategic
development as a research organization (known as
institutional funding). The aim of the schemes is to
maintain and improve the quality and quantity of
research outputs at the University not only on a
national level, but also internationally. The funders
had no role in study design, data collection and
analysis, decision to publish, or preparation of the
manuscript.
Competing Interests: The authors have declared
that no competing interests exist.
showed, that early limited formula may reduce longer-term formula use at 1 week and increase
breastfeeding at 3 months for some infants [11].
A study focusing on the problems experienced by breastfeeding mothers shows that one of
the most common reasons cited by mothers who opt to stop breastfeeding in early neonatal
period is anxiety over insufficient milk supply [12]. The physiological process of onset of lacta-
tion does not usually occur immediately after delivery; instead it may take up to several days
for mature milk production to settle in. It is the relatively small volumes of colostrum and the
unsettled behaviour of the newborn prone to dissatisfaction during these first days of life that,
despite offered reassurance, may be misinterpreted by the mother as insufficient milk supply
and lead to early cessation of breastfeeding. Approaches to this problem vary widely. Although
some, including The Baby Friendly Hospital Initiative promote elimination of supplementary
top-up formula feeds for healthy infants [13], others perceive benefits from early supplementa-
tion of other fluids or foods. Optimizing clinical practice regarding establishing breastfeeding
and formula use during early neonatal period may prove to have a major impact on overall
health benefit for newborn infants, if this helps to prolong overall breastfeeding duration and
raise the numbers of ideally exclusively breastfed infants up to 6 months of age.
In this study, we aim to investigate the role and effect of limited formula use on breastfeed-
ing and its discontinuation. The primary outcome is to investigate the rates of exclusive as well
as any breastfeeding at 3 months of age. We hypothesize, that early limited formula feeds in
infants with early weight loss will not adversely affect the rates of exclusive or any breastfeeding
in short-term and long-term. Infants who lose 5% or more of their birth weight during the first
48 hours after delivery are known to be at higher risk of excessive weight loss and hence are
at higher risk of eventual formula supplementation as well as the risk of maternal concern
regarding insufficient milk supply with the feared result of shorter breastfeeding duration.
These at risk newborns may hence benefit from an early limited formula use, where the given
controlled amounts for a limited time would not be expected to interfere with breastfeeding as
recommended.
Materials and Methods
The study was conducted at the Institute for the Care of Mother and Child in Prague. Patients
were recruited from the 1
st
of April 2014 until the 29
th
of August 2014. Follow up was com-
pleted on the 27
th
of February 2015. The trial was registered in the ISRCTN registry with the
ID number ISRCTN61915183. As trial registration is not required in advance of performing a
study that has been approved by the ethics committee in Czech Republic, patient recruitment
was commenced before the trial was registered for the purpose of publication. The authors con-
firm that all ongoing and related trials for this intervention are registered.
Infants were eligible for randomisation when their weight loss was 5 per cent between
24
th
and 48
th
hour of life. Only healthy, singleton, appropriate for gestational age (AGA) term
neonates, born after uncomplicated pregnancy and delivery, who had no severe congenital
defects were enrolled. Mothers of the included infants were planning to breastfeed for a long
time and all were Czech citizens. Mothers with serious complications (hypertension, diabetes,
systemic diseases, drug abuse) or using therapy that might affect breastfeeding (antidepres-
sants) were excluded. Written informed consent was obtained from all mothers by a study doc-
tor. This study, including the consent procedure, was approved by the Local Ethics Committee
and Local Committee on Human Research on the 19
th
of December 2013 (The Ethics Commit-
tee on Clinical Trial on Human Medicinal Products, Prague 4).
To estimate the sample size, data from the randomized controlled trial published by Flaher-
man et al. [11] were used instead of performing a preliminary study. For the given effect size
Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 3/12
(population proportions of 0.95 versus 0.75) and alpha (0.05 2-tailed) with power of 0.80, the
estimated sample sizes are 49 in each group. This means that 80% of studies would be expected
to yield a significant effect, rejecting the null hypothesis that the two population proportions
are equal. The sample size estimation was performed using the software SamplePower 3.
Using the sealed envelope technique and randomization with permuted blocks, we ran-
domly assigned 104 mother-infant pairs to either controlled limited formula group (CLF) or
standard approach group (SA). The randomization sequence was generated and the sealed
envelopes in blocks of 8 were prepared by the hospitalsadministration office staff.
All mothers irrespective of assigned study group were educated by a specialised nurse
regarding breastfeeding. As part of the hospitalsstandard service, all to be mothers are offered
optional participation in antenatal educational courses of 2 hours duration and are informed in
antenatal clinics regarding the possibility of obtaining information about breastfeeding from
the hospital website, available printed leaflets and rentable short movie. In addition all mothers
take part in a general breastfeeding session of 60 minutes duration on the ward during the
birth hospitalisation, participation in this session was made mandatory for all mothers partici-
pating in the study. Specialised nurses supervise all breastfeeding mothers regarding breast-
feeding techniques on the wards until breastfeeding is established as a routine hospital practice
and additional help was available on mothersrequest. All participating mothers were asked
about the used sources of breastfeeding information and the response noted in the case report
form (not analysed for the purpose of the study).
Infants in the controlled limited formula group (CLFintervention group) were given a set
volume of 10ml of formula (HIPP NE, HIPP Inc., Germany) after each breastfeed until ade-
quate milk production began. Infants in the standard approach group (SAcontrol group)
were exclusively breastfed. Supplemental feeds were administered only in indicated cases. This
included excessive weight loss (more than 10% of birth weight), irritability of the newborn, in
terms of unsettling cry and hungry behaviour, and on mothers specific request. Infants in the
control group, if requiring supplemental feeding, were given breastmilk from the breastmilk-
bank or formula according to the motherschoice. All formula feeds were always given using
the syringe-technique.
The primary outcome measures were the rates of any breastfeeding and of exclusive breast-
feeding at 3 months of the infants´ age. The secondary outcome measures included the rates of
any breastfeeding and exclusive breastfeeding at the time of hospital discharge and at 6 months
of the infants´ age, as well as the percentage weight loss during birth hospitalisation. Clinical
data for all infants involved, including any complications occurring during the hospitalisation,
were collected prospectively and recorded using a case report form. Using transcutaneous mea-
surement of bilirubin by Icterometer (Minolta Air Shields Jaundice Meter JM-103), all partici-
pants have been regularly checked for hyperbilirubinaemia as according to standard hospital
guidelines. Levels of bilirubin above 200 umol/l have been recorded, as per standard hospital
guidelines levels of serum-bilirubin were measured and all cases requiring phototherapy noted.
A research nurse who was blinded to group allocation assessed outcomes during a personal
interview at discharge and by a telephone-interview at 3 and 6 months of the infantsage.
Breastfeeding was assessed on questioning the mother, firstly on exclusive breastfeeding and
secondly on any breastfeeding with closed questions and answers recorded as yes or no.
Data was analysed using descriptive statistic methods. We used the Chi-Square Test of inde-
pendence, or Fishers Exact Test for comparison of groups of categorised variables and the
Mann-Whitney test for comparison of numerical variables. All p-values are calculated at level
of significance of 0.05 (alpha = 0.05) and adjusted for multiple testing using the Bonferroni cor-
rection when appropriate. Statistical analysis was performed using the software IBM SPSS Sta-
tistics 22.0.0.1.
Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 4/12
Results
Participant characteristics
Overall 52 (50%) infants were assigned to controlled limited formula group (CLF) and 52
(50%) to standard approach group (SA). Two participants from each group failed to complete
the study, 50 participants in each group were analysed. Fig 1 shows the numbers of mother-
infant pairs at enrolment, allocation, follow-up and for analysis.
All mothers involved in the study were planning and wishing to breastfeed over long term.
Thematernal demographic parameters and general clinical characteristics of participating
infants in each of the intervention groups are shown in Table 1.
Delivery of the intervention and control
The intervention of controlled limited formula was delivered to 50 infants in the intervention
group. Only 11 out of 50 (22%) infants in the control group were exclusively breastfed during
hospitalisation. Supplemental feeding was needed in 39 cases (78%) within the control group.
Out of these cases 31 (80%) were given breastmilk from the breastmilk-bank and 8 (20%) were
given formula on specific parental request. In 10 cases within the control group, supplemental
feeds were given from medical indication of excessive weight loss of 10% of birth weight dur-
ing the hospitalisation, in all of the remaining cases in the control group, supplemental feeds
were given on repeated and explicit parental demand. The maximum total volume of supple-
mental feeds given was 400ml in the CLF group and 475ml in the control group. The median
amount of total volume of supplemental feeds given was 60 ml (interquartile range of 56) in
the CLF group and 20ml (interquartile range of 90) in the control group. (See Table 2.)
Rates of breastfeeding
Our analysis showed no evidence of a difference in rates of exclusive breastfeeding as well as
that of any breastfeeding at any time point among participants allocated to the intervention
and control groups. The percentage of breastfeeding mothers however tends to be higher
among those of the CLF group compared to the control group in both exclusive and any breast-
feeding, particularly at 3 and 6 months of the infantsage although this is not statistically signif-
icant and the percentage of mothers with any breastfeeding at discharge are very similar. The
data are summarised in Table 3. The number of times a mother has attempted to breastfeed
during hospitalisation (between enrolment and discharge) is higher in the control group com-
pared to CLF group (p-value 0.01, shown in Table 1).
The rates of exclusive breastfeeding at discharge, 3 and 6 months of age were not affected by
the mode of delivery (vaginal versus cesarean section) or presence/absence of skin to skin con-
tact in delivery room. No evidence of difference was shown when looking at the rates of exclu-
sive breastfeeding at discharge, 3 and 6 months of infantsage irrespective of treatment group
as well as when analysis was performed only at 3 months (primary outcome) adjusted for treat-
ment arm. These results are summarised in Tables 4and 5.
Weight loss in participating newborn infants
Although there was no statistically significant difference in birth weights or weights at enrol-
ment between the intervention groups, there was a significant difference in the maximal body
weight loss (expressed in percentminus 7.3% in CLF group and minus 8.4% in control group
respectively, p = 0.002). At the point of study enrolment, there were no infants with weight loss
10% of their birth weight, however eleven cohort infants lost 10% of their birth weight
Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 5/12
during the study, including 1 (2%) of 50 in the CLF group and 10 (20%) of 50 in the control
group (p = 0.004). The comparison of weight changes are shown in Fig 2.
Complications
Llevels of bilirubin above 200 umol/l were found in 8 cases (16%) in the CLF group and in 18
cases (36%) in the control group. This difference is statistically significant (p-value 0.02), Only
1 of all the cases, a participant from the control group, required phototherapy treatment (last-
ing 48 hours overall). There were no events of hypoglycaemia, gastrointestinal problems
including feeds intolerance, sepsis, or diagnosis of neuromuscular disorders, inborn errors of
metabolism and birth defects noted in any of the participating infants. No complications affect-
ing ability to breastfeed were reported by any of the participating mothers.
Discussion
Our study compared the use of controlled limited supplemental formula feeding with the stan-
dard clinical practice regarding the effect on initiation and maintenance of breastfeeding.
Many hospitals, as opposed to the aim of Baby Friendly Hospitals Initiative, do use uncon-
trolled amounts of supplemental feeding [14] as part of their standard practice, as it is often
asked for by parents. This approach tends to be linked to effectivity of breastfeeding. In con-
trast to some existing literature discouraging from the use of supplemental formula feeding
during birth hospitalisation [8,9], our results show no evidence of difference in the rates of
exclusive as well as any breastfeeding between participants allocated to the intervention of
Fig 1. Flow chart of the randomized study.
doi:10.1371/journal.pone.0150053.g001
Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 6/12
controlled and limited formula use as compared to those allocated to the control group. The
study supports our hypothesis that supplemental controlled and limited formula feeding of at
risk infants with weight loss of 5% birth weight does not adversely affect the rates of exclu-
sive and any breastfeeding in short and long term. There seems to be a tendency shown by the
slightly higher percentage of breastfeeding mothers in the CLF group at 3 and 6 months of the
infantsage, which may suggest that controlled limited formula use during birth hospitalisation
may actually support the onset of lactation and improve maintenance of breastfeeding in lon-
ger term in these cases, however due to lack of statistical significance, this needs to be con-
firmed in a larger study.
In this study, supplemental feedings were strictly defined in terms of amounts (these were
chosen so that the newborns´ demand for breastfeeding would be maintained and would not
Table 1. Demographic and Clinical Characteristics of the Study Groups.
Controlled and limited formula
(Intervention group, n = 50)
Standard approach (Control
group, n = 50)
P
value
Gestational age,wk, mean ±SD 39.3 ±1.0 39.4 ±1.1 0.35
Birth weight,g, mean ±SD 3367 ±305 3324 ±307 0.52
Weight at enrolment,g, mean ±SD 3158 ±282 3113 ±288 0.42
Infantsage at enrolment,hours, mean ±SD (95% CI) 31.3 ±6.1 (CI 29.633.0) 32.0 ±5.6 (CI 30.433.6) 0.35
Length of hospitalisation,days, mean ±SD (95% CI) 4 ±0.7 (3.84.2) 4.4 ±1.0 (4.14.7) 0.11
Number of breastfeeding attempts*, mean ±SD (95% CI) 21.7 ±7.0 (19.823.7) 26.5 ±9.5 (23.829.2) 0.01
Number of breastfeeding attempts normalized to lenght of
stay, mean ±SD (95% CI)
8.2 ±1.8 (7.68.7) 8.9 ±1.8 (8.49.4) 0.02
Transcutaneous icterometry >200 umol/l, n (%) 8 (16%) 18 (36%) 0.02
Maternal age, years, mean ±SD 31.6 ±4.2 32.1 ±4.0 0.47
Primiparous, n (%) 27 (54) 27 (54) >0.99
Mode of delivery, n (%) 0.72
Vaginal delivery 32 (64) 30 (60)
Acute Cesarean section 5 (10) 7 (14)
Elective Cesarean section 13 (26) 13 (26)
Mother with high school or more education, n (%) 47 (94) 48 (96) 0.84
Skin-to-skin at delivery room, n (%) 29 (58) 30 (60) 0.84
Plan to breastfeed, n (%) 50 (100%) 50 (100%) >0.99
Abbreviations:
*= Number of breastfeeding attempts during hospitalisation (i.e. between enrolment and discharge)
doi:10.1371/journal.pone.0150053.t001
Table 2. Comparison of supplemental feeds given by intervention group.
Controlled and limited formula
(Intervention group, n = 50)
Standard approach
(Control group, n = 50)
Volume of supplemental feeds
given overall, ml
median 60 20
1
st
quartile 40 2,5
3
rd
quartile 96 92,5
Interquartile range 56 90
Maximum total volume of
supplemental feeds given, ml
400 475
doi:10.1371/journal.pone.0150053.t002
Influence of Limited Formula on Breastfeeding Rate
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interfere with the recommended [13] 8 to 12 breastfeeding times per day), form (always using
the syringe to avoid nipple confusion that may be associated with bottle feeding) and duration
(controlled limited formula feeding was terminated as soon as breastfeeding was established).
This approach differs from some clinical practices of unstructured formula supplementation.
Another way the controlled formula supplementaion may support and improve breastfeeding
is the fact that it possibly alleviates maternal concerns regarding insufficient milk production.
This is known to be one of the common reasons for breastfeeding discontinuation [12]. As
shown, infants of the CLF group proved to have significantly lower maximal bodyweight loss
and significantly lower rates of excessive weight loss (10%) as compared to the control group.
By improving the infantsweight and possibly hydration status, the behavioural pattern in
terms of newborns dissatisfaction might also be improved, hence supporting the mother in her
intention to continue breastfeeding whilst awaiting onset of mature milk production. In addi-
tion as formula usage after onset of lactation is associated with possible reduction in lactation
and early cessation of breastfeeding [9] and knowing that infants with greater weight loss are at
higher risk of their mothers opting to continue formula supplementation after breastfeeding is
established [12], giving early controlled formula amounts for limited time may help to reduce
the actual use of formula in longer term and hence improve the rates of breastfeeding or even
exclusive breastfeeding at later time point. In the authorsopinion, the general pressure on
excluding supplemental formula feeding from birth hospitalisation, whilst being relevant with
respect to some clinical approaches, may unintentionally potentially lower the chances of
breastfeeding for some at risk cohorts that could be possibly identified and helped with the
strategy of controlled limited formula feeding.
According to the available data on breastfeeding rates within Czech Republic, the overall
rate of exclusive breastfeeding at 3 months of age is 33% and that of breastfeeding to some
Table 3. Breastfeeding rates by Study Group. P-values adjusted for multiple testing using Bonferroni correction.
Controlled and limited formula
(Intervention group, n = 50)
Standard approach
(Control group, n = 50)
P-
value
Adjusted p-
value
Odds ratio 95% Condence
Interval
Exclusive breastfeeding at
discharge, n (%)
49 (98) 44 (88) 0.11 0.22 6.68 0.7757.69
Breastfeeding at
discharge, n (%)
50 (100) 49 (98) >0.99 >0.99 Not
applicable
Not applicable
Exclusive breastfeeding at
3 month, n (%)
42 (84) 34 (68) 0.06 0.12 2.47 0.946.46
Breastfeeding at 3 month,
n (%)
46 (92) 39 (78) 0.05 0.10 3.24 0.9611.00
Exclusive breastfeeding at
6 month, n (%)
32 (64) 26 (52) 0.22 0.45 1.64 0.743.66
Breastfeeding at 6 month,
n (%)
40 (80) 34 (68) 0.17 0.34 1.88 0.764.69
doi:10.1371/journal.pone.0150053.t003
Table 4. Comparison of the rates of exclusive breastfeeding in accordance to mode of delivery and skin-to-skin contact irrespective to patient
group allocation.
Mode of delivery Skin to skin contact
Rate of exclusive breastfeeding Vaginal Caesarean section p-value YES NO p-value
at discharge (%) 93.5 92.1 0.61 93.2 92.7 0.63
at 3 months (%) 77.4 73.7 0.7 79.7 70.7 0.54
at 6 months (%) 56.5 60.5 0.49 57.6 58.5 0.63
doi:10.1371/journal.pone.0150053.t004
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extent at 3 months is 62% [15]. Both of the groups observed in this study (CLF and SA) have
achieved higher breastfeeding rates than the national average (84% and 68% respectively).
Moreover, comparison with published data of the Baby Friendly Hospitals Initiative within
Czech Republic, where the breastfeeding rates achieved at discharge are given as 86% [16], the
breastfeeding rates at discharge in the CLF group are higher (98%), whereas those of the con-
trol group, i. e. the standard clinical approach (88%) are comparable.
Interestingly, in our cohort no statistically significant difference for breastfeeding at dis-
charge and 3 or 6 months of age was found with respect to skin-to-skin contact occurance in
delivery room and with respect to mode of delivery (vaginal or cesarean section). These,
although being valid recommendations to help establish and maintain exclusive breastfeeding,
do not seem to be the only determinants of breastfeeding success.
The fact that the number of breastfeeding times/attempts is significantly higher in the con-
trol group (p-value 0.02) even when normalized to length of stay, may be due to increased
Table 5. Comparison of rates of exclusive breastfeeding in accordance to mode of delivery and skin-to-skin contact, adjusted for treatment arm.
Mode of delivery Skin to skin contact
Rate of exclusive breastfeeding Vaginal Caesarean section YES NO
CLF group (%) 64.3 35.7 60 40
Control group (%) 61.8 38.2 65 35
p-value 0.82 0.64
doi:10.1371/journal.pone.0150053.t005
Fig 2. Differences in weight loss by intervention group. Median, first and third quartiles are shown, as
well as the minimal and maximal values for birth weightwhite box, weight at enrollmentstriped box, lowest
weightdotted box, weight at dischargegrey box. Statistically significant difference in weight loss between
groups is shown.
doi:10.1371/journal.pone.0150053.g002
Influence of Limited Formula on Breastfeeding Rate
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maternal effort to exclusively breastfeed. The significantly higher number of newborns with
jaundice in control group (hyperbilirubinaemia of >200 umol/l as measured by transcutaneous
icterometer, p-value 0.02) corresponds with published data on hyperbilirubinaemia in exclu-
sively breastfed infants [17].
The limitations of our study include mainly the low rate of exclusively breastfed newborn
infants for the entire duration of birth hospitalisation. Overall 78% of infants in the control
group were given a supplemental feed at some point during the hospitalisation. Considering
the inclusion criteria of the study (weight loss 5% of birth weight at enrolment), this may be
underlining the need for a strategy alleviating maternal concerns, as in this group supplemental
feeding, if not indicated medically (excessive weight loss, signs of dehydration), was only given
at mothers explicit wish and all mothers were equally motivated to exclusively breastfeed at the
time of enrolment. Comparing the given volumes of supplemental feeds in the two groups, the
median of the control group is much lower than that in the CLF group, however the interquar-
tile range (90 in control group compared to 56 in CLF group) shows the greater variety of the
given amounts of supplemental feeds, in some cases comprising of larger amounts than the
median amount given in the CLF group. This is due to the presence of few individuals in need
of large amounts of supplemental feeds who may have skewed the distribution within the
group. The relatively large number of newborns given supplemental feeds within the control
group also limits the possibility for comparison with the CLF group, as the comparison mainly
comprises controlled and limited versus uncontrolled formula feeding rather than formula
feeding versus exclusive breastfeeding. This practical limitation of the study method with
inability of prohibiting supplemental feeds in standard hospital practice might have contrib-
uted to the fact that differences in the breastfeeding rates have not been statistically significant
and could have been expected to be greater in values. Another published study of similar
design, comparing exclusive breastfeeding with early limited formula supplementation during
birth hospitalisation in healthy term newborns with 5% birth weight loss has shown statisti-
cally signifacnt difference at 3 months in favour of the early limited formula feeding. In this
randomized controlled study 15 (79%) of 19 infants assigned to the intervention group during
the birth hospitalisation were breastfeeding exclusively, compared with 8 (42%) of 19 controls
(P = 0.02) at 3 months of the infantsage [11]. In order to minimise possible influence of the
given supplementational feeds, most infants in the control group were offered breast milk from
breastmilk-bank (80% of all supplementational feeds in the control group), unless the parents
wished explicitly for formula.
Another study limitation is posed by the highly selected cohort of mother-newborn pairs.
The inclusion criteria exclude a large population of newborn infants (e.g. pre-term, small or
large for gestational age) that might also benefit from improval of breastfeeding rates, however
supplemental feeding and perhaps further supportive nutritional measures that may have to be
taken due to many different reasons, make comparison difficult. In addition, the inclusion cri-
teria of 5% body weight loss contributes to select specifically at risk infants, where foresee-
able problems arise especially for exclusive breastfeeding throughout birth hospitalisation and
hence mainly for the control group. This might have an effect on the achieved breastfeeding
rates within this group, with a trend to lower breastfeeding rates than in the CLF group. The
mothers involved in our study also possibly represent only a selected part of population. The
recruitment of participating mother-infant pairs took place within one hospital only. There are
relatively large regional differences with respect to education, income and invariably overall
breastfeeding rates as well as numbers of mothers with the intention to exclusively breastfeed
for longer term, all of which can affect the results of our comparison. Hence further research
would be needed to confirm our results in larger sample size as well as in a population with
greater diversity and better representation of regional differences.
Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 10 / 12
In conclusion, the study shows that controlled limited formula use does not have an adverse
effect on rates of breastfeeding in short and long term and may support establishing breastfeed-
ing, as well as potentially help to improve the rates of breastfeeding overall.
Supporting Information
S1 Table. CONSORT checklist.
(DOC)
S2 Table. Data set. (Raw data set of the study.)
(DOCX)
S1 Text. Study protocol original.
(PDF)
S2 Text. Case Report Form. (Original document in Czech language.)
(PDF)
Acknowledgments
With thanks to all participating mothers and their newborn babies.
Author Contributions
Conceived and designed the experiments: ZS SF MC JK. Performed the experiments: MC JK.
Analyzed the data: ZS SF MC JK. Wrote the paper: ZS SF JF. Reviewed the article for important
intellectual content: JF.
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Influence of Limited Formula on Breastfeeding Rate
PLOS ONE | DOI:10.1371/journal.pone.0150053 February 26, 2016 12 / 12
... A similar trial in 2016 by Stranak et al. with 100 infants, found no differences in the rate of breast feeding initiation and its duration. [73]. Schbiger et al. randomized 602 infants to either restrictive supplement or pacifiers vs. conventional feeding practices during the first 5 days of life (supplementation after breastfeeding and pacifiers were offered without restriction) [74]. ...
... Exclusive breastfeeding is difficult to establish especially for primiparous women and evidence suggests that supplemental feedings are not related to decrease exclusive breastfeeding rates [18,72,73]. Term infants with weight loss ≥ 5% from birth weight, are at special risk and supplemental feedings should be considered [72,73]. ...
... Exclusive breastfeeding is difficult to establish especially for primiparous women and evidence suggests that supplemental feedings are not related to decrease exclusive breastfeeding rates [18,72,73]. Term infants with weight loss ≥ 5% from birth weight, are at special risk and supplemental feedings should be considered [72,73]. Currently, supplementation of feeding is still controversial. ...
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Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2016) and reference lists of all relevant retrieved papers. Selection criteria Randomised or quasi-randomised controlled trials in infants under six months of age comparing exclusive breastfeeding versus breastfeeding with any additional food or fluids. Data collection and analysis Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach. Main results We included 11 trials (2542 randomised infants/mothers). Nine trials (2226 analysed) provided data on outcomes of interest to this review. The variation in outcome measures and time points made it difficult to pool results from trials. Data could only be combined in a meta-analysis for one primary (breastfeeding duration) and one secondary (weight change) outcome. None of the trials reported on physiological jaundice. Infant mortality was only reported in one trial. For the majority of older trials, the description of study methods was inadequate to assess the risk of bias. Most studies that we could assess showed a high risk of other biases and over half were at high risk of selection bias. Providing breastfeeding infants with artifical milk, compared to exclusive breastfeeding, did not affect rates of breastfeeding at hospital discharge (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.97 to 1.08; one trial, 100 infants; low-quality evidence). At three months, breastfeeding infants who were provided with artificial milk had higher rates of any breastfeeding compared to exclusively breastfeeding infants (RR 1.21, 95% CI 1.05 to 1.41; two trials, 137 infants; low-quality evidence). Infants who were given artifical milk in the first few days after birth before breastfeeding, had less "obvious or probable symptoms" of allergy compared to exclusively breastfeeding infants (RR 0.56, 95% CI 0.35 to 0.91; one trial, 207 infants; very low-quality evidence). No difference was found in maternal confidence when comparing non-exclusive breastfeeding infants who were provided with artificial milk with exclusive breastfeeding infants (mean difference (MD) 0.10, 95% CI -0.34 to 0.54; one study, 39 infants; low-quality evidence). Rates of breastfeeding were lower in the non-exclusive breastfeeding group compared to the exclusive breastfeeding group at four, eight, 12 (RR 0.68, 95% CI 0.53 to 0.87; one trial, 170 infants; low-quality evidence), 16 and 20 weeks. 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We reviewed the evidence on the effects of breastfeeding on short- and long-term infant and maternal health outcomes in developed countries. We searched MEDLINE(R), CINAHL, and the Cochrane Library in November of 2005. Supplemental searches on selected outcomes were searched through May of 2006. We also identified additional studies in bibliographies of selected reviews and by suggestions from technical experts. We included systematic reviews/meta-analyses, randomized and non-randomized comparative trials, prospective cohort, and case-control studies on the effects of breastfeeding and relevant outcomes published in the English language. Included studies must have a comparative arm of formula feeding or different durations of breastfeeding. Only studies conducted in developed countries were included in the updates of previous systematic reviews. The studies were graded for methodological quality. We screened over 9,000 abstracts. Forty-three primary studies on infant health outcomes, 43 primary studies on maternal health outcomes, and 29 systematic reviews or meta-analyses that covered approximately 400 individual studies were included in this review. We found that a history of breastfeeding was associated with a reduction in the risk of acute otitis media, non-specific gastroenteritis, severe lower respiratory tract infections, atopic dermatitis, asthma (young children), obesity, type 1 and 2 diabetes, childhood leukemia, sudden infant death syndrome (SIDS), and necrotizing enterocolitis. There was no relationship between breastfeeding in term infants and cognitive performance. The relationship between breastfeeding and cardiovascular diseases was unclear. Similarly, it was also unclear concerning the relationship between breastfeeding and infant mortality in developed countries. For maternal outcomes, a history of lactation was associated with a reduced risk of type 2 diabetes, breast, and ovarian cancer. Early cessation of breastfeeding or not breastfeeding was associated with an increased risk of maternal postpartum depression. There was no relationship between a history of lactation and the risk of osteoporosis. The effect of breastfeeding in mothers on return-to-pre-pregnancy weight was negligible, and the effect of breastfeeding on postpartum weight loss was unclear. A history of breastfeeding is associated with a reduced risk of many diseases in infants and mothers from developed countries. Because almost all the data in this review were gathered from observational studies, one should not infer causality based on these findings. Also, there is a wide range of quality of the body of evidence across different health outcomes. For future studies, clear subject selection criteria and definition of "exclusive breastfeeding," reliable collection of feeding data, controlling for important confounders including child-specific factors, and blinded assessment of the outcome measures will help. Sibling analysis provides a method to control for hereditary and household factors that are important in certain outcomes. In addition, cluster randomized controlled studies on the effectiveness of various breastfeeding promotion interventions will provide further opportunity to investigate any disparity in health outcomes as a result of the intervention.
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Although the health benefits of breastfeeding are acknowledged widely, opinions and recommendations are divided on the optimal duration of exclusive breastfeeding. We systematically reviewed available evidence concerning the effects on child health, growth, and development and on maternal health of exclusive breastfeeding for 6 months vs. exclusive breastfeeding for 3–4 months followed by mixed breastfeeding (introduction of complementary liquid or solid foods with continued breastfeeding) to 6 months. Two independent literature searches were conducted, together comprising the following databases: MEDLINE (as of 1966), Index Medicus (prior to 1966), CINAHL, HealthSTAR, BIOSIS, CAB Abstracts, EMBASE-Medicine, EMBASE-Psychology, Econlit, Index Medicus for the WHO Eastern Mediterranean Region, African Index Medicus, Lilacs (Latin American and Carribean literature), EBM Reviews-Best Evidence, the Cochrane Database of Systematic Reviews, and the Cochrane Controlled Trials Register. No language restrictions were imposed. The two searches yielded a total of 2,668 unique citations. Contacts with experts in the field yielded additional published and unpublished studies. Studies were stratified according to study design (controlled trials vs. observational studies) and provenance (developing vs. developed countries). The main outcome measures were weight and length gain, weight-for-age and length-for-age z-scores, head circumference, iron status, gastrointestinal and respiratory infectious morbidity, atopic eczema, asthma, neuromotor development, duration of lactational amenorrhea, and maternal postpartum weight loss. Twenty independent studies meeting the selection criteria were identified by the literature search: 9 from developing countries (2 of which were controlled trials in Honduras) and 11 from developed countries (all observational studies). Neither the trials nor the observational studies suggest that infants who continue to be exclusively breastfed for 6 months show deficits in weight or length gain, although larger sample sizes would be required to rule out modest increases in the risk of undernutrition. The data are conflicting with respect to iron status but suggest that, at least in developing-country settings, where iron stores of newborn infants may be suboptimal, exclusive breastfeeding without iron supplementation through 6 months of age may compromise hematologic status. Based primarily on an observational analysis of a large randomized trial in Belarus, infants who continue exclusive breastfeeding for 6 months or more appear to have a significantly reduced risk of one or more episodes of gastrointestinal tract infection. No significant reduction in risk of atopic eczema, asthma, or other atopic outcomes has been demonstrated in studies from Finland, Australia, and Belarus. Data from the two Honduran trials suggest that exclusive breastfeeding through 6 months of age is associated with delayed resumption of menses and more rapid postpartum weight loss in the mother. Infants who are breastfed exclusively for 6 months experience less morbidity from gastrointestinal tract infection than infants who were mixed breastfed as of 3 or 4 months of age. No deficits have been demonstrated in growth among infants from either developing or developed countries who are exclusively breastfed for 6 months or longer. Moreover, the mothers of such infants have more prolonged lactational amenorrhea and faster postpartum weight loss. Based on the results of this review, the World Health Assembly adopted a resolution to recommend exclusive breastfeeding for 6 months to its member countries. Large randomized trials are recommended in both developed and developing countries to ensure that exclusive breastfeeding for 6 months does not increase the risk of undernutrition (growth faltering), to confirm the health benefits reported thus far, and to investigate other potential effects on health and development, especially over the long term.
Article
Our goal was to assess the impact of "Baby-Friendly" hospital practices and other maternity-care practices experienced by mothers on breastfeeding duration. This analysis of the Infant Feeding Practices Study II focused on mothers who initiated breastfeeding and intended prenatally to breastfeed for >2 months, with complete data on all variables (n = 1907). Predictor variables included indicators of 6 "Baby-Friendly" practices (breastfeeding initiation within 1 hour of birth, giving only breast milk, rooming in, breastfeeding on demand, no pacifiers, fostering breastfeeding support groups) along with several other maternity-care practices. The main outcome measure was breastfeeding termination before 6 weeks. Only 8.1% of the mothers experienced all 6 "Baby-Friendly" practices. The practices most consistently associated with breastfeeding beyond 6 weeks were initiation within 1 hour of birth, giving only breast milk, and not using pacifiers. Bringing the infant to the room for feeding at night if not rooming in and not giving pain medications to the mother during delivery were also protective against early breastfeeding termination. Compared with the mothers who experienced all 6 "Baby-Friendly" practices, mothers who experienced none were approximately 13 times more likely to stop breastfeeding early. Additional practices decreased the risk for early termination. Increased "Baby-Friendly" hospital practices, along with several other maternity-care practices, improve the chances of breastfeeding beyond 6 weeks. The need to work with hospitals to implement these practices continues to exist, as illustrated by the small proportion of mothers who reported experiencing all 6 of the "Baby-Friendly" hospital practices measured in this study.
Article
To avoid methodologic pitfalls in previous observational studies linking formula supplementation in the hospital to early discontinuation of breast-feeding, a controlled clinical trial of restricted supplementation was conducted. In a pretrial sample of 621 newborns, a comparison of two "well-baby" nurseries found no differences in either hospital supplementation practices or the proportion of infants still being breast-fed at 4 or 9 weeks postpartum. Restriction of supplementation in one of the nurseries for the trial period (n = 781) did not result in higher breast-feeding rates at 4 or 9 weeks. There was, however, a slightly greater mean percent of birth weight lost in the restricted group (6.0% v 5.1%; P less than .001). In examining the control group for evidence of an "observational" association, it was found that infants still breast-feeding at 4 or 9 weeks were far more likely to have been unsupplemented than those no longer being breast-fed. It thus appears that formula supplementation in the hospital is a marker, rather than a cause, of breast-feeding difficulty.
Article
Exclusive breastfeeding for six months (versus three to four months) reduces gastrointestinal infection, does not impair growth, and helps the mother lose weight. The results of two controlled trials and 18 other studies suggest that exclusive breastfeeding (no solids or liquids besides human milk, other than vitamins and medications) for six months has several advantages over exclusive breastfeeding for three to four months followed by mixed breastfeeding. These advantages include a lower risk of gastrointestinal infection, more rapid maternal weight loss after birth, and delayed return of menstrual periods. No reduced risks of other infections or of allergic diseases have been demonstrated. No adverse effects on growth have been documented with exclusive breastfeeding for six months, but a reduced level of iron has been observed in developing-country settings.