On May 13, 2013 the American Academy of Pediatrics published a study in their journal Pediatrics looking at the effects of Early Limited Formula on the duration of exclusive breastfeeding. As many outraged bloggers and health professionals pointed out in the days following its publication, the sample size was small and can hardly represent a larger population of women outside of the San Francisco area.
But there are some very overlooked facets of the study that I feel warrant additional criticism. Per definition, any infant who receives ANY breast milk substitutes in the first 6 months of life can no longer be considered "exclusively" breastfeeding for research purposes. It does not matter if an infant gets 1 bottle and is exclusively breastfed afterwards. For the sake of research, that infant cannot be considered exclusively breastfed.
Therefore, Early Limited Formula (ELF) does not increase exclusive breastfeeding rates. It is, by its very existence, a detriment to exclusive breastfeeding. That doesn't mean that ELF doesn't have its place, and as demonstrated by this study most of the mothers who gave ELF went on to wean entirely off the supplement and breastfeed their infants without supplementation. [1]
Which brings me to my second criticism: Early Limited Formula. ELF is not the haphazard feeding of formula to neonates "just because". It is a strictly controlled method of delivering formula supplements to infants who have a clinical indication, in a way that does not undermine breastfeeding. The women in the supplementation group gave only 10 mL's of formula via a syringe after each breastfeed. Infants who were assigned to the study were those who had lost > 5% of their birth weight in the first 24 hours of life. Such dramatic weight loss is correlated with overall weight loss of >10%. The formula supplements were discontinued at 3-5 days postpartum, when the mother's milk volume increased.
By their mere participation, the women in the supplementation group received additional education on the proper supplementation of a breastfed infant. By having strictly controlled formula amounts and a set timeline, these women were inadvertently educated on newborn stomach size as well as clinically indicated supplementation amounts. The ELF supplements were administered by a study nurse, who also educated them on how to supplement. That makes them much less likely to go home and try and give their baby a 2 ounce "top up" bottle of ready-to-feed (the most common form of formula given out to new moms as samples) .
This is education that the control group missed out on. In the study, the women in the control group were given education on an infant soothing technique.
This study shows that it's not the supplementation itself that benefits breastfeeding rates, but it's actually HOW you supplement. Many women stop exclusively breastfeeding because they perceive their supply to be low. They give overly large bottles, which results in the newborn's stomach stretching, flow preference developing, and breastfeeding becomes even more difficult.
Going off of 20 years of research, hospital supplementation of newborns is almost always correlated with reduced breastfeeding rates. This study has far too small of a sample size, with far too many clinical errors, to be considered groundbreaking. It does nothing to counter-act decades of research. [2],[3],[4]
Some other criticisms of the study:
1. Did the >5% weight loss in the first 24 hours control for women who received IV fluids? IV fluids given during labor pass through the placenta and over-inflate the newborn's birth weight. In the first 24 hours, the infant will urinate out much of that fluid, which results in a dramatic % weight loss. [6]
2. Not all of the women were on equal footing when it came to breastfeeding experience. The ELF group contained more multiparous women, and they even admitted that 78% of multiparous women were still breastfeeding at 3 months vs 33% of primaparous mothers.
3. Why formula and not donor milk? Pasteurized donor milk has been found to be a safe and effective supplement for newborns. [7],[8] This study has the side effect of promoting/justifying the use of infant formula, when really it was the supplementation method itself that had the effect and not the choice of supplement.
This study also brings up ethical concerns. Given that there are very real hazards associated with giving infants formula, the randomization of infants to receive either formula supplementation or exclusive breast milk is troubling. The criteria for including infants in the study only mentions that they had lost >5% of their birth weight. That alone should not be considered cause for supplementation. So by randomizing infants to receive possibly unnecessary formula supplements, this study has the potential to be considered unethical.
There are a number of "interventions" that have all been positively correlated with longer duration of breastfeeding:
1. Early initiation of breastfeeding. The sooner after birth a mother initiates breastfeeding, the more likely she is to continue breastfeeding after discharge. Higher rates of formula supplementation are associated with newborns born on the night shift, where access to IBCLC's and lactation support is more scant. [4]
2. Prenatal childbirth and breastfeeding education. Prenatal breastfeeding education is very positively correlated with greater breastfeeding initiation as well as longer breastfeeding duration. [4]
3. Staff support of breastfeeding, hospital policy, and home-based peer counseling. This includes things like formula samples, rooming-in, staff support of breastfeeding, and education of nursing staff on breastfeeding. Baby-Friendly Hospital Initiative is also positively associated with better breastfeeding outcomes, [5] as are peer-counseling programs.
References:
1. American Academy of Pediatrics. 2013. "Effect of Early Limited Formula on Exclusivity and Duration of Breastfeeding in At-Risk Infants"
http://pediatrics.aappublications.org/content/early/2013/05/08/peds.2012-2809.abstract
2. American Academy of Pediatrics. 1991. "Early Formula Supplementation of Breastfeeding"
http://pediatrics.aappublications.org/content/early/2013/05/08/peds.2012-2809.abstract
3. American Academy of Pediatrics. 1985. "Effect of Formula Supplementation in the Hospital on the Duration of Breastfeeding."
http://pediatrics.aappublications.org/content/75/3/514.short
4. Journal of Human Lactation. 2005. "In-Hospital Formula Supplementation of Healthy Breastfeeding Newborns"
http://jhl.sagepub.com/content/21/4/397.short
5. American Academy of Pediatrics. 2001. "Baby-Friendly Hospital Initiative Improves Breastfeeding Initiation Rates in a US Hospital Setting"
http://www.pediatricsdigest.mobi/content/108/3/677.short
6. International Breastfeeding Journal. 2011. "An observational study of associations among maternal fluids during parturition, neonatal output, and breastfed newborn weight loss"http://www.internationalbreastfeedingjournal.com/content/6/1/9/abstract
7. Journal of Human Lactation. 2001. "Donor Milk: What's in It and What's Not?"
http://jhl.sagepub.com/content/17/2/152.short
8. American Academy of Pediatrics. 2012. "Breastfeeding and the Use of Human Milk"
http://pediatrics.aappublications.org/content/129/3/e827.full
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