Supplementation with small volumes of formula before mature milk production may improve long-term breast-feeding compliance among infants who lost 5% or more of their body weight within 36 hours after birth, according to the findings of a randomized trial.
Valerie J. Flaherman, MD, PhD, from the University of California, San Francisco, and colleagues publish their findings in an article published online May 13 in Pediatrics.
The researchers note that measures are needed to improve breast-feeding compliance. "[A]lthough 74% of US infants initiate breastfeeding, only 30% maintain exclusive breastfeeding through 3 months and only 21% are still breastfeeding at 12 months," the authors write. "Optimizing clinical and public health approaches to improving breastfeeding duration in the United States might have a large beneficial effect on infant and maternal health."
In the study, the authors randomly assigned 40 exclusively breast-feeding, full-term infants between 24 and 48 hours of age who lost 5% or more of their body weight within 36 hours after birth to receive either limited amounts of formula after breast-feeding or exclusive breast-feeding, and assessed breast-feeding rates after 1 week and 1, 2, and 3 months.
The authors excluded infants who lost 10% or more of their body weight, those who had received formula or water, those with mothers younger than 18 years, those who required a higher level of care than a level 1 nursery, and those with mothers who could not speak English or Spanish or who were producing mature milk.
No differences were observed between the 2 groups at baseline. After 1 week, although all 39 evaluable infants were still being breast-fed, 9 of 19 infants in the exclusive breast-feeding group had received formula within the preceding 24 hours compared with 2 of 20 infants in the formula supplementation group (risk difference, 37%; 95% confidence interval, 3.4% - 71.0%; P = .01).
At 3 months, 15 of 19 infants in the formula supplementation group were exclusively breast-feeding compared with 8 of 19 infants in the exclusive breast-feeding group (P = .02). Moreover, 18 of 19 infants in the formula supplementation group were breast-feeding to some extent compared with 13 of 18 infants in the exclusive breast-feeding group (P = .04).
Although delayed onset of lactation did not affect overall breast-feeding rates, it was associated with a lower likelihood of exclusive breast-feeding at 3 months (P < .01). The limitations of the study included the small sample size, which precluded subgroup and multivariate regression analyses; a lack of diversity in the study population; and a lack of data on infectious and allergic outcomes.
"Further research is needed to confirm [these findings] in a larger and more diverse population, and to determine whether any such reduction in total formula use is associated with improved health outcomes," the authors write.
"[T]he authors are to be commended for tackling an important clinical problem, that of optimizing exclusive breastfeeding outcomes," writes Lydia Furman, MD, from Rainbow Babies and Children's Hospital in Cleveland, Ohio, in a related commentary. "However, to evaluate early limited formula objectively, we need protocols that explicitly optimize lactation and enroll mother-infant dyads clearly at risk for poor breastfeeding outcomes; any early limited formula strategy should await these data."
The study was supported by funding from the National Institutes of Health. One coauthor has served as a paid consultant for Abbott Nutrition, Mead-Johnson, Nestle SA, and Pfizer Consumer Products. The other authors and Dr. Furman have disclosed no relevant financial relationships.
Pediatrics. Published online May 13, 2013.
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