Investigators from the University of California San Francisco and Penn State College of Medicine, Hershey, PA, conducted a randomized controlled trial (RCT) to assess the effect of early limited formula (ELF) for breastfed infants on breastfeeding duration and hospital readmission and to explore the impact of ELF on intestinal microbiota through 1 month of age. Exclusively breastfed infants, born at >37 weeks’ gestation, whose weight loss was >75th percentile for age as measured by The Newborn Weight Tool, a nomogram for plotting weight loss in infants shortly after birth, were recruited for the study. Study participants who were randomized to the ELF intervention received 10 mL of extensively hydrolyzed formula after each feeding via syringe until the onset of copious maternal milk production. Infants in the control group were exclusively breastfed unless formula was recommended by a health care provider. The mothers of study participants were contacted at 1 week and 1 month and asked if their babies were receiving breast milk feedings, and about receipt of any formula within the past 24 hours. At the 1-week follow-up, mothers were queried regarding hospital readmission in their babies. Differences in these outcomes were assessed with chi-square or Fisher exact tests. In a subgroup of babies, stool samples were collected for microbiota analyses; multiple statistical tests were used to compare the abundance of Lactobacillus, Clostridia, and Bacteroides.
A total of 164 newborns were enrolled in the study (82 in the intervention group and 82 controls), and 152 (92.7%) completed the 1-month follow-up. The mean age at enrollment was 36 hours; mean weight loss since birth was 6.3 + 1.6% among those randomized to ELF and 6.4 + 1.5% in controls. Breastfeeding rates were not significantly different between infants in the intervention and control groups at 1 week (95.8% and 93.6%, respectively, P=.54) or at 1 month (86.5% and 89.7%, respectively, P=.53). At the 1-week follow-up, 36.7% of participants randomized to ELF had received formula in the past 24 hours compared to 22.4% of those in the control group (P=.08). At the 1-month follow-up, rates of formula use in the past 24 hours were 45.5% and 34.3%, respectively (P=.18). Four babies in the control group were readmitted during the first week of life versus 0 of those in the intervention group (P=.06). Stool specimens were collected on 15 infants, including 8 in the ELF group. No statistically significant differences in the abundance of Lactobacillus, Clostridia, and Bacteroides were detected between infants in the 2 groups.
The authors conclude that ELF did not interfere with breastfeeding rates through 1 month of life or intestinal microbiota.
Commentary
Dr Chung has disclosed no financial relationship relevant to this commentary. This commentary does not contain discussion of the investigative use of a commercial product.
Breastfeeding success is dependent on many factors, including intention, initiation in the first hour of life, exclusivity, social and family supports, and hospital-based and community support. The anticipated neonatal weight loss following birth is more pronounced in breastfed newborns and those delivered by cesarean section,1 adding to parental and clinician anxiety. The decision to supplement with formula should not be based solely on weight loss.2 Consider urine output and hunger cues. Prior to supplementation, clinicians may determine the mother’s milk supply, assist with hand expression, and optimize breast milk provision. When clinicians feel that supplementation is indicated, donor milk is preferred, when available.
The results of the current study suggest that there is no apparent harm by ELF on breastfeeding at 1 month, and there is no negative impact on intestinal bacteria. However, the study population lacked race/ethnic diversity and included only full-term infants, which may limit its applicability to the general population. The authors of the present study note that revisions to Joint Commission quality measures should be considered to permit use of ELF. In fact, the Joint Commission allows for formula use for “newborn medical conditions,” including hypoglycemia, weight loss, and hyperbilirubinemia, and hospital quality scores are not negatively impacted in these instances.3
Exclusive breastfeeding is not always possible for mother-infant dyads. ELF research raises interesting questions about how clinicians might approach the challenging situation of supporting breastfeeding in the context of today’s short birth hospitalizations. The results of the present study add to the growing literature on controlled approaches to supplementation and to our understanding of neonatal intestinal microbiota.
Bottom Line
ELF use does not appear to have an impact on breastfeeding at age 1 month or intestinal microbiota for breastfed, full-term infants.
EDITORS’ NOTE
Kudos to the authors of the current study for challenging conventional wisdom with a well done RCT on the effect of ELF on relevant breastfeeding outcomes. A larger RCT will be needed to adequately to determine if ELF reduces the risk of hospital readmission. The results of past, current and, hopefully, future studies should inform breastfeeding policy and practice.
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