Trial Information

The Impact of a Breastfeeding Support Intervention on Breastfeeding Duration in Jaundiced Infants Admitted to a Tertiary Care Centre: a Randomized Controlled Trial.

1.1 Overview This study will assess the effectiveness of a breastfeeding support
intervention for infants admitted to the hospital with jaundice. It will evaluate the effect
of this intervention on duration of breastfeeding and health care utilization.

1.2 Study Objectives: Primary: To determine the effect of a breastfeeding support
intervention on breastfeeding duration in breastfeeding infants admitted to the hospital
with jaundice.

Secondary:

- To determine the rate of breastfeeding failure, defined as breastfeeding cessation
before the infant turns 6 months, in mothers of jaundiced infants randomized to the
control group, as compared to the rate of breastfeeding failure in the general
population.

- To compare subsequent healthcare utilization between groups during their first six
months of life, as determined by the number of re-hospitalizations for jaundice,
hospitalizations for non-jaundice related causes, as well as physician encounters.

- To determine the number of mothers seeking breastfeeding help once discharged from the
hospital and compare it between both groups.

- To determine the kind and perceived effectiveness of breastfeeding support and advice
given by the infant's primary physician throughout the child's first six months of
life.

2.1 Summary: Breastfeeding confers many advantages to infants, mothers, families, and
society in general. There is strong evidence that human milk feeding decreases the
incidence of many infectious diseases and enhances the immunologic status of the newborn.
It has been associated with enhanced performance on neurocognitive development tests, and
has also been shown to provide important health benefits to the mother, including a decrease
in risk of breast and ovarian cancers. It should be strongly encouraged for the first six
months of life, and then continued for up to 2 years and beyond, as recommended in the World
Health Organization's Innocent Declaration.

Neonatal jaundice is the most common problem in full-term infants during the immediate
post-natal period. There is controversy as to whether breastfeeding increases the incidence
of jaundice in the first days of life. In a study conducted in Italy, neonatal jaundice was
not associated with breastfeeding per se, but rather with increased weight loss after birth
subsequent to fasting, which can be seen with inadequate lactation.

When an infant is hospitalized, previously established patterns of breastfeeding are
difficult to maintain. There is evidence to suggest that mothers of young infants admitted
to hospital with hyperbilirubinemia commonly experience guilt as they feel breastfeeding
caused the jaundice. Many of these women struggle with feelings of failure or inadequacy.
A study recently conducted by the principal investigator of this current study (CP)
suggested that infants admitted to the hospital with hyperbilirubinemia may have a higher
rate of breastfeeding discontinuation than babies in the general population.

Previous studies have shown that breastfeeding support offered to various groups of
mother-infant pairs significantly increased rates of breastfeeding at 2 to 6 months of age.

Given the clear health, social and economic advantages that breastfeeding confers to
mothers, infants, and society in general, there is a need to assess the effectiveness of a
breastfeeding support intervention for infants admitted to the hospital with jaundice.

2.2 Benefits of breastfeeding Breastfeeding is preferred for all infants, and exclusive
breastfeeding of infants is recommended for the first 6 months after birth. Research has
shown that human milk feeding decreases the incidence of multiple illnesses including
bacterial meningitis, bacteremia, diarrhea, respiratory tract infection, otitis media, and
urinary tract infections. A recent study conducted in Spain showed that exclusive
breastfeeding lowered the risk of hospitalization as a result of infectious diseases during
the first year of life. In that study, each additional month of exclusive breastfeeding
would have avoided 30% of hospital admissions. A meta-analysis of 33 studies examining
healthy infants in developed nations showed similar results, with formula-fed infants
experiencing a tripling in severe respiratory illnesses compared with those who were
exclusively breastfed for 4 months. Based on these results, breastfeeding promotion can
lead to important economical gains from a societal perspective.

According to the most recent Ottawa Public Health Survey, breastfeeding rates in the general
population are as follows: 91% of women initiate breastfeeding, with 56% practicing
exclusive breastfeeding (no fluids other than breast milk). At 3 months, 71% of women
continue to breastfeed, with 50% doing exclusive breastfeeding. This number drops to 60%
for any breastfeeding at 6 months, with 39% of women exclusively breastfeeding.

2.3 Breastfeeding in hospitalized children Published reports have shown that previously
established patterns of breastfeeding are hard to maintain once an infant is hospitalized.
Moreover, as mentioned, evidence suggests that mothers of infants admitted to the hospital
with jaundice experience guilt, as well feelings of failure and inadequacy as they often
feel responsible for the child's admission to hospital. Maternal confidence has been shown
to be a strong predictor of breastfeeding duration, with lack of confidence in breastfeeding
skills leading to a higher likelihood of weaning in the first six weeks post-partum. There
is only one study in the literature examining the rates of breastfeeding in the jaundiced
population, which was done by the PI of this current study. Surveys were sent to all
mothers of eligible infants admitted with jaundice to the Children's Hospital of Eastern
Ontario (CHEO) over a 2.5 year period. One hundred and twenty-eight (64%) out of the 200
eligible mothers returned a completed survey. Of those, 92% had a post-secondary education.
Information was collected, retrospectively, on length of breastfeeding after discharge from
the hospital. Length of breastfeeding for hospitalized infants was compared to that of the
Ottawa population, as reported by the City of Ottawa Public Health survey in 2005. Although
numbers were the same between the jaundiced group and the City of Ottawa group, it is likely
that the high education level of the study participants falsely elevated the rate of
breastfeeding in the jaundiced infants. As mentioned, 92% of study participants had
completed a post-secondary education, as compared to 53% of women involved in the
population-based survey. Given that previous reports have shown that women with lower
levels of education are more likely to discontinue breastfeeding early, it is reasonable to
postulate that for comparable levels of education, mothers of infants admitted to the
hospital with jaundice discontinue breastfeeding earlier than women in the general
population.

2.4 Breastfeeding support interventions There are very few studies quantifying the effects
of breastfeeding promotion interventions. A recent Cochrane review found that both
professional and lay support were effective in prolonging breastfeeding. More specifically,
this review found that professional support had more of an impact than lay support on both
partial and exclusive breastfeeding and lay support affected exclusive breastfeeding. A
review of four randomized controlled trials combining breastfeeding support with educational
programs in developed countries found that combined education and support strategies
increased short-term breastfeeding rates by 36%. Short-term breastfeeding in these studies
was described as anywhere between 2 to 6 months. The education interventions were primarily
conducted by lactation specialists or nurses as antepartum sessions, while the support
interventions varied between telephone or in-person conversations, hospital or home visits
by lactation consultants, nurses or peer counselors, and combined prearranged appointments
and unscheduled visits or telephone calls for problems. Breastfeeding education and support
had the biggest effect on initiation and maintenance of breastfeeding. Many of the studies
however lacked scientific rigor. Most studies did not make a difference between exclusive
and partial breastfeeding. Details regarding description and length of interventions as
well as training of the individual delivering the educational session were often lacking.

A recent randomized controlled trial evaluating the effectiveness of a breastfeeding
promotion intervention in the Republic of Belarus19 found an absolute increase of almost 37%
in the prevalence of exclusive breastfeeding at 3 months in the intervention group. The
chief obstetrician from each intervention maternity hospital, and the chief pediatrician
from each intervention polyclinic, received the same 18-hour courses emphasizing methods to
maintain lactation, promote exclusive and prolonged breastfeeding, and resolve common
problems. All midwives, nurses and physicians providing care to study mothers and infants,
as well as all pediatricians and nurses working in the polyclinics were trained over a
period of 12 to 16 months. Such a program offered the advantage of providing reliable and
consistent support, with the goal of being widely available. This study was published after
the Cochrane review and thus is not included in the review.

Although no study published to date has determined which aspect of a breastfeeding support
intervention yields positive results, it is likely to result from a combination of factors.
Breastfeeding support results in increased confidence, and maternal confidence is known to
be a strong predictor of breastfeeding outcome, with lack of confidence in breastfeeding
skills leading to a higher likelihood of weaning in the first six weeks post-partum.

2.5 Availability of breastfeeding support In the recent CHEO study, 57% of the participating
mothers needed to seek breastfeeding support after discharge from the hospital, suggesting
they did not receive adequate help while hospitalized. Half of these women received help
from private lactation consultants. These lactation consultants have variable training and
may or may not hold recognized certifications or credentials. Their fees also vary from 10$
to 90$ an hour, and therefore may not be a suitable alternative for families with financial
difficulties. This indicates the need for a standardized breastfeeding support intervention
that will be accessible to all.

2.6 Breastfeeding and health care professionals Many studies have shown that physicians and
physicians in training lack the necessary skills to offer proper guidance to lactating
mothers. Freed et al surveyed pediatric residents and practitioners about breastfeeding
knowledge and found that both groups had considerable knowledge deficits, and were
ill-prepared for counseling mothers with lactation difficulties. Many residents surveyed in
a study performed by Hillenbrand et al believed that early supplementation was not a cause
of breast-feeding failure, although previous studies have clearly demonstrated this
relationship. In the Ottawa study, only 3.9% of women reported receiving breastfeeding help
from the treating physician while admitted to the hospital, suggesting the possibility that
physicians do not have adequate knowledge to assess proper breastfeeding methods and counsel
appropriately.

In summary, there is a need for this comprehensive study examining the impact of a
breastfeeding support intervention for mothers of infants admitted to the hospital with
jaundice. This study will clarify the rates of early breastfeeding discontinuation in the
jaundiced population and help determine whether physicians in the Ottawa population have
knowledge deficits when it comes to breastfeeding, as there may be a role for incorporating
teaching of breastfeeding skills to physicians and physicians in training.