Early Limited Formula Is Not Ready for Prime Time

Abstract

All research should challenge existing paradigms and beliefs, and the article by Flaherman and colleagues on early limited formula as a strategy to promote exclusive breastfeeding does just that.1 The authors are respected contributors to the literature on breastfeeding. However, there are critical limitations to study design that bring their conclusion into question and restrict the generalizability of their results. All elements of the protocol, from inclusion and exclusion criteria to intervention content and timing, should receive careful evaluation before we accept the authors' conclusions.

Formula Supplementation of Breastfed Infants

“…However, expert consensus guidelines do not consider a 5% weight loss as a contributor to adverse health outcomes, 4 and the study design has been noted to have critical limitations (Box 1) including a coauthor who functions as a consultant for 4 formula companies. 8 Nonmedically indicated formula supplementation can cause unintentional harm to the lactation process, to the breastfeeding relationship, to the infant, and to the mother, leaving even more problems in its wake. Lacked maternity unit protocols to optimize early exclusive breastfeeding outcomes…”

“…However, expert consensus guidelines do not consider a 5% weight loss as a contributor to adverse health outcomes, 4 and the study design has been noted to have critical limitations (Box 1) including a coauthor who functions as a consultant for 4 formula companies. 8…”

Of Elves and Ethics

“…ELF’s authors acknowledge their small sample size, which prevents the study from saying anything generalizable. They also describe infants who lost ≥ 5% of birth weight as “at risk” due to “high early weight loss.” Such weight loss is normal , 2 thus, as another commentary put it, the study intervenes on “infants who are not in need of intervention.” 3 In addition, critics 3,4 worry that improved long-term breastfeeding in the intervention group simply reflects increased hands-on feeding help over the control group and suggest comparing formula supplementation with donor milk or mother’s own milk supplements. But why not just eliminate the formula?…”