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Randomized Trial of Breastfeeding Support in Very Low-Birth-Weight Infants
Janet Pinelli, RNC, MScN, DNS;
Stephanie A. Atkinson, PhD, RD;
Saroj Saigal, MD
Arch Pediatr Adolesc Med. 2001;155:548-553.
ABSTRACT
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Objective To determine if supplementary structured breastfeeding counseling (SSBC)
for both parents compared with conventional hospital breastfeeding support
(CHBS) improves the duration of breastfeeding in very low-birth-weight infants
up to 1 year old.
Design Randomized trial with longitudinal follow-up of infants at term, and
ages 1, 3, 6, and 12 months (infant ages corrected for prematurity).
Setting A tertiary-level neonatal intensive care unit (NICU) and geographically
defined region in central-west Ontario, Canada.
Participants Parents of infants with a birth weight less than 1500 g, who planned
to breastfeed.
Interventions The SSBC consisted of viewing a video on breastfeeding for preterm infants;
individual counseling by the research lactation consultant; weekly personal
contact in the hospital; and frequent postdischarge contact through the infants'
first year or until breastfeeding was discontinued. The CHBS group had standard
breastfeeding support from regular staff members confined to the period of
hospitalization in the NICU.
Main Outcome Measure Duration of breastfeeding.
Results At study entry, there were no statistically significant differences
in major demographic characteristics between groups. The mean duration of
breastfeeding was 26.1 weeks (SD = 20.8; median, 17.4) in the SSBC group and
24.0 weeks (SD = 20.5; median, 17.4) in the CHBS group (not statistically
significant).
Conclusions Long-term breastfeeding counseling of parents of very low-birth-weight
infants in this study did not demonstrate a significant difference in duration
of breastfeeding. These results may be explained by the high motivation to
breastfeed in both groups, a relatively advantaged population, and the availability
of community breastfeeding resources, which may have diminished any significant
differences that could have resulted from a breastfeeding intervention. The
results of this study, compared with previous studies of very low-birth-weight
infants, indicate a new trend to longer duration of breastfeeding in preterm
infants.
INTRODUCTION
CURRENT guidelines in Canada and the United States recommend that the
first choice for premature infant nutrition is fortified mother's milk.1, 2 Recommendations from Canada include
fortification of the milk until the infant is breastfeeding effectively, followed
by exclusive breastfeeding until age 4 to 6 months (infant ages are corrected
for prematurity).1 Despite these recommendations,
there is a wide variation in the reported incidence of breastfeeding in very
low-birth-weight (VLBW) infants born preterm. The percentage of women who
initiate breastfeeding ranges from 33% to 91%,3, 4, 5, 6
with the incidence in the United States in the lower range,7, 8, 9, 10
and Scandinavian countries at the higher ranges.11
The duration of breastfeeding in the preterm population, according to
the reported literature, also varies widely and is confounded by the range
of prematurity and the definition of breastfeeding in these studies. The duration
reported in previous studies ranges from approximately 2 to 6 months, with
a shorter duration of breastfeeding in infants born at very low gestational
ages in comparison with the more mature preterm infants.4, 5, 7, 8, 11, 12, 13, 14
Mothers of the very premature infants have significant difficulties in making
the transition from expressing milk to feeding directly at the breast. Incidence
of an inability to feed at the breast ranged from 37% to 79% in reported studies.4, 5, 14 During the initial
hospitalization, establishing and maintaining a supply of milk must be initiated
without the assistance of the infant and must rely primarily on artificial
stimulation of the breast. Knowledge of breastfeeding for most parents does
not include information on pumping and maintaining a milk supply for extended
periods. Because of parental concerns for the infant, and/or maternal illness,
initiation of pumping is often delayed, which may exacerbate difficulties
in establishing an adequate supply of milk. Delayed initiation and the need
to maintain a supply for long periods may result in perceived or actual deficiencies
in milk supply. Not surprisingly, concerns related to milk production and
transfer of milk to the infant are reported to be the primary reasons for
discontinuing breastfeeding or for providing supplementation.5, 11, 15, 16
There is no doubt that breastfeeding preterm infants poses greater challenges
for mothers than the breastfeeding of infants carried to term. Health professionals
who are involved with preterm infants and their mothers need to be knowledgeable
of the issues related to breastfeeding, and of the specific interventions
that are reported to enhance the success of breastfeeding in this population.
To date, the issues related to pumping milk and establishing breastfeeding
in hospital have received more attention than the problems with maintenance
of breastfeeding after hospital discharge.
Interventions designed to enhance breastfeeding success through support
of the mother–preterm infant dyad have been studied, but few randomized
trials have been conducted. These studies used interventions that were primarily
educational and supportive in nature, such as advice on breast milk expression
and collection, nutritional information, emotional support, plans for postdischarge
breastfeeding management, and general newborn care.10, 17, 18
While these nonexperimental studies reported an increase in the incidence
and duration of breastfeeding as a result of their programs, 2 of the studies
provided no data on the incidence or duration prior to initiation of the breastfeeding
program.10, 18
The main purpose of the present study was to determine whether a supplementary
structured breastfeeding counseling program (SSBC) for parents of preterm
infants, compared with conventional hospital-based breastfeeding support (CHBS),
will improve the duration of lactation and the success of breastfeeding after
discharge from the hospital, and up to age 1 year. This study also explored
nutritional and neurodevelopmental outcomes, but these will be addressed in
a separate article.
SUBJECTS AND METHODS
SUBJECTS
The setting for the study was a 33-bed, tertiary-level neonatal intensive
care unit (NICU) of a teaching hospital that is the referral center for a
geographically defined region in central-west Ontario, delivering approximately
29 000 infants per year. Inclusion criteria were: infants with birthweights
less than 1500 g (VLBW), who were inborn or transferred with their mother
within 72 hours of birth if they were outborn, and fed mother's milk by parental
choice. Exclusion criteria were: multiple births; infants with severe congenital,
surgical, or chromosomal abnormalities; and non–English-speaking parents.
Fathers, as well as mothers, were included in this study because of the recognized
importance of partners as a key support to breastfeeding success.19 The sample size was based on the difference between
the success rate (approximately 10%) of breastfeeding at age 3 months at the
initiation of the study, and the desired success rate defined for the study,
which was 30%. Using proportional tables,  levels of .05, ß levels
of .2, and a 1-tailed test, 58 infants per group (116 infants total) were
needed to detect a statistically significant difference between groups.20 Using formulation for survival analysis, the sample
size calculation was somewhat smaller (103 infants).21
This type of analysis assumes that the drop-off rate of breastfeeding is exponential.
In our experience and that of others,3, 13, 14, 15
the rate of breastfeeding drops off fairly precipitously at about 6 to 8 weeks
postnatally and may not be exponential. Therefore, we chose a conservative
sample size of 128 infants.
All parents who met the inclusion criteria were approached by a research
assistant to participate in the study. After obtaining informed consent, infants
were stratified by birth weight ( 1000 g or >1000 g) and parents were randomly
assigned, using random-number tables and sealed opaque envelopes, to receive
either CHBS (n = 64 couples) or SSBC (n = 64 couples) within 72 hours of birth.
The SSBC consisted of (1) viewing a video on breastfeeding preterm infants;
(2) individual counseling by the research lactation consultant, who was not
a member of the hospital staff; (3) weekly personal in-hospital contact; and
(4) frequent postdischarge contact through the infant's first year or until
breastfeeding was discontinued. The CHBS group had standard support confined
to the period of hospitalization in the NICU, which included contact with
the regular hospital staff (ie, nurses, nutritionists, neonatal nurse practitioners,
physicians). No specialized breastfeeding clinic was available to parents
in the hospital at the time of the study, and only a limited number of staff
had any formal education in lactation or breastfeeding support.
Demographic and breastfeeding history and practice information was collected
by means of self-administered questionnaires that were distributed to the
mothers in both groups at study entry, prior to hospital discharge, and during
3-, 6-, and 12-month follow-up visits. Partners completed questionnaires separately
from mothers at study entry and at the 6-month visit. The breastfeeding questionnaires
were developed from the literature and from those used in previous research
by one of this article's authors (J.P.).22
The questions included choices for set answers, as well as the opportunity
for parents to write their comments. During hospitalization, the 24-hour volume
of expressed milk was recorded once per week from the milk brought to the
NICU. After discharge from the NICU, the infants were seen during their scheduled
visits to the Growth and Development Clinic at the Children's Hospital of
the Hamilton Health Sciences Corporation (Hamilton, Ontario), at the "due
date," and at 3, 6, and 12 months of age. At each follow-up visit, the volume
of a single feed intake was assessed by prebreastfeeding and postbreastfeeding
test weights of infants done on an electric scale accurate to 1.0 g, and by
feeding records and mother's report. Breastfeeding exclusivity, or percent
human milk intake of total fluid intake, was determined using the following
categories: greater than 80%, 50% to 80%, less than 50%, and no breastfeeding.
These categories were based on the recommendations by Labbock and Krasovec,23 relating to definitions of breastfeeding.
STATISTICAL ANALYSIS
Data were analyzed as groups were assigned at entry to the study. The
initial analysis of the breastfeeding questionnaires was conducted using descriptive
statistics. The primary outcome of interest in this study was the duration
and success of breastfeeding. Duration of breastfeeding was measured as a
continuous variable; that is, in weeks, and was analyzed using survival analysis
techniques. For percent of human milk intake, breastfeeding exclusivity was
analyzed using the  2 test of proportions at each visit. Lastly,
a Cox regression model was used to determine predictors of breastfeeding duration.
The level of statistical significance was set at P<.05.
RESULTS
STUDY ENTRY
The demographic variables of the study participants are presented in Table 1. Parents in both groups were generally
aged in their late 20s to early 30s, white, living with a partner, and with
a relatively high socioeconomic status. There were no significant differences
between the groups in any of the infant variables. The mean duration of months
that mothers in both groups planned to breastfeed was 8 months (SD, 3.6 months;
range, 0.5-24 months), which was similar to the mean duration they planned
to stay home from work (7.6 months; SD, 7.8 months; range, 0-60 months). These
results indicate that both cohorts of parents were highly committed to breastfeeding.
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Table 1. Demographic Variables by Study Group*
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Specific information about the type of pump used was not collected;
however, most mothers in our NICU are encouraged to use an electric pump if
they are intending to pump for longer than 1 month. In addition, the usual
practice for gavage feeding preterm infants is to use an intermittent orogastric
tube. Infants who will be breastfed are not usually given breast milk by bottle
and will be gavage fed until breastfeeding is fully established or until the
infant consistently demonstrates a negative reaction to the gavage tube, such
as gagging.
The majority of mothers in both groups rated breastfeeding as very important,
both for providing milk and for putting the infant to breast. Maternal perceptions
of the importance of breastfeeding to their partners was reported as "very
important." In addition, the majority of partners rated breastfeeding as "very
important" to themselves as well as to their partners. The views of the partners
regarding the duration the infant should breastfeed was similar to the plans
of the mothers for breastfeeding; that is, approximately 8 months. At study
entry, there were no statistically significant differences between the groups
for any sociodemographic variables, decision to breastfeed, importance of
breastfeeding, breastfeeding knowledge, and lifestyle factors.
NICU BREASTFEEDING EXPERIENCE
With respect to their breastfeeding experiences in the NICU, mothers
in both groups reported similar findings. There were no differences between
groups in the variables related to breast milk expression. Infants were put
directly to breast at a mean ± SD age of 25 ± 23 days in the
SSBC group, and at a mean ± SD age of 25 ± 18 days in the CHBS
group (Table 2). About half of
the mothers in the SSBC and CHBS groups (47% vs 53%, respectively) reported
that the cost of the pump was "somewhat" of a burden, compared with an "extreme"
burden (20% in both groups), or "not at all" (33% vs 27%, respectively). The
main problem mothers reported having with breastfeeding in the NICU was a
sleepy infant (39% vs 43% in SSBC and CHBS groups, respectively). The majority
of infants in both groups were being gavage fed at the time of discharge from
the NICU to the local community hospitals for convalescent care, with about
12% in both groups receiving some bottles.
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Table 2. NICU Experience of Mothers: Comparison of Groups*
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BREASTFEEDING EXPERIENCE AT HOME
More than 50% of mothers in both groups experienced breastfeeding problems
at home, as reported at the 6-month assessment. The greatest percentage of
problems in both groups was reported at the 1-month assessment (94% vs 81%
for SSBC and CHBS, respectively). Mothers in both groups reported several
breastfeeding problems at home during all periods, including sore nipples,
fatigue, not enough milk, infant not gaining weight, and infant not being
interested in breastfeeding. There were no statistically significant differences
between groups except for mothers' reports of the infant not gaining weight,
which was more frequent in the SSBC group (P = .05).
In both groups, mothers' reports of insufficient milk supply was the most
frequent problem at home for all periods. Not surprisingly, the main reasons
for discontinuing breastfeeding mirrored the problems experienced by the mothers.
At all times, except at 12 months, mothers in both groups discontinued breastfeeding
because they perceived that they were not producing enough breast milk. At
12 months, the main reason for discontinuation was that the infant was no
longer interested in breastfeeding. It is important to note that none of the
mothers in either group identified their partners as a reason for stopping
breastfeeding at any given time.
Mothers in both groups reported using a wide variety of breastfeeding
resources for solving breastfeeding problems at home, including health professionals,
books, friends, and family. The large number of mothers who had public health
nurses at the due date assessment likely reflects the fact that these infants
were discharged home around that time. When all time periods were combined,
the most used resource for advice on breastfeeding for both groups was the
lactation consultant (which included the research lactation consultant in
the study group and community lactation consultants in both groups).
MAIN OUTCOME MEASURES
The main outcome for this study was duration and success of breastfeeding
to age 1 year. Figure 1 shows the
analysis of breastfeeding duration based on the Kaplan-Meier test. The mean
duration of breastfeeding was 26.2 weeks (SE, 2.7 weeks; 95% confidence interval
[CI], 21.0-31.5; median, 17.4 weeks) in the SSBC group, and 24.2 weeks (SE,
2.7 weeks; 95% CI, 19.0-29.4; median, 17.4 weeks) in the CHBS group, which
was not significantly different. Percent of human milk intake was determined
through single-feed prebreastfeeding and postbreastfeeding test weights, feeding
records, and mother's report. Table 3
indicates that the breastfeeding exclusivity, by group, at all time periods
was also not statistically significant. A Cox regression analysis on the combined
sample determined smoking to be a significant negative factor (P = .003), and number of months planning to breastfeed to be a significant
positive factor (P = .003) for breastfeeding duration.
Nonsignificant factors were infant's gestational age, mother's time away from
work, maternal age, parity, socioeconomic status, and total amount of milk
pumped in 24 hours in the NICU.
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Kaplan-Meier analysis of breastfeeding duration. CHBS indicates conventional
hospital breastfeeding support; SSBC, supplementary structured breastfeeding
counseling; and censored, only cases that experienced the terminal event (ie,
discontinued breastfeeding by 12 months of corrected age).
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Table 3. Breastfeeding Exclusivity by Supplementary Structured Breastfeeding
Counseling (SSBC) and Conventional Hospital Breastfeeding Support (CHBS) Groups
at All Time Periods*
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COMMENT
In this open, randomized trial, long-term breastfeeding support of parents
of VLBW infants did not result in a significant difference in the duration
of breastfeeding. The high motivation to breastfeed in both groups, prior
breastfeeding experience, a relatively advantaged socioeconomic population,
and the widespread availability of community resources (lactation consultants,
public health nurses, family physicians, breastfeeding support groups) to
support breastfeeding may have diminished any significant differences resulting
from a breastfeeding support intervention. This study of parents of VLBW infants
is unique in the inclusion of partners in the breastfeeding intervention and
in the long-term follow-up of breastfeeding to age 1 year.
In a preintervention and postintervention study,12
counseling of mothers of infants in an NICU significantly increased the incidence
and the mean duration of breastfeeding. However, the breastfeeding rates were
higher among mothers who were white and privately insured, regardless of counseling.
Similarly, positive effects of breastfeeding support in term infants from
families with low socioeconomic status have been reported.25, 26, 27, 28
Other intervention studies on VLBW infants have also demonstrated stronger
and more consistent differences in cognition in infants from economically
disadvantaged environments than in infants from middle-class families or families
with high maternal education.29, 30
It is possible that the intervention tested in the current study might demonstrate
a difference in populations of VLBW infants of lower socioeconomic status,
or at least in populations that are less homogeneous in terms of ethnicity,
socioeconomic status, health insurance coverage, and maternal education.
The results of this study, compared with those of retrospective studies
in preterm infants, indicate a trend toward longer duration of breastfeeding.
Previous studies of preterm infants indicate a mean duration of breastfeeding
ranging from 1.8 to 5.6 months.4, 5, 7, 8, 11, 12, 14, 15
It is difficult to compare studies, however, because of the lack of consistency
in the definition of breastfeeding and in the wide range of the birth weights
and maturity of the infants included in the studies. The breastfeeding exclusivity
results from this study indicate that infants generally received either greater
than 80% human milk intake or no human milk intake, with few infants receiving
intakes between those percentages.
In this study, there was a significant number of mothers in whom milk
supply continued to be problematic for much of the infant's first year of
life. For these mothers, supportive interventions alone do not seem to influence
breastfeeding success. As in other studies,31
cigarette smoking was a negative predictor of breastfeeding duration; thus,
education to reduce or eliminate smoking might improve breastfeeding outcomes.
Since the decision about planned duration of breastfeeding was a positive
influence on breastfeeding outcome, early education of mothers to support
such planning may be useful.
With respect to implications for clinical practice, the anecdotal and
research literature suggest that supporting parents of preterm infants is
important to breastfeeding success. The negative results of this study should
not be perceived as an indication that breastfeeding support is not helpful.
Further studies are required to determine the effectiveness of this model
in a more disadvantaged population and those with limited access to community
resources.
AUTHOR INFORMATION
Accepted for publication November 30, 2000.
This study was funded by grant 6606-5242-VF from the National Health
Research Development Program, Ottawa, Ontario.
Presented at the Pediatric Academic Societies & American Academy
of Pediatrics Joint Meeting, San Francisco, Calif, May 2, 1999.
We gratefully acknowledge the statistical consultation provided by Harry
Shannon, PhD. We would like to thank our research team: Janis Randall-Simpson,
PhD, Susan Steele, RN, Michelle Whelan, RN, Miriam Chang, MSc, and Beverly
Marchment, BSc. We especially thank the parents and infants who participated
in the study.
From the School of Nursing (Dr Pinelli) and the Department of Pediatrics
(Drs Atkinson and Saigal), McMaster University, Hamilton, Ontario; and the
Children's Hospital of the Hamilton Health Sciences Corporation, Hamilton
(Dr Pinelli).
Corresponding author: Janet Pinelli, RNC, Msc, DNS, Faculty of Health
Sciences, Room 3N25D, McMaster University, 1200 Main St W, Hamilton, Ontario
L8N 3Z5, Canada (e-mail: pinellij{at}fhs.mcmaster.ca).
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