Early Postpartum Formula Supplementation and Breastfeeding Rates at 6-12 months
by Anne Eglash MD, IBCLC, FABM
Breastfeeding newborns sometimes need supplementation in the first few days postpartum for medical indications such as a delay in lactation, low milk supply, excessive weight loss, poor feeding at the breast or late-preterm status.
But what happens if all newborns are supplemented based solely on the degree of weight loss, before it becomes medically indicated? Does that impact breastfeeding success? One theory has been that if excessive weight loss can be prevented by small amounts of formula supplementation early, then larger volumes of formula supplementation can be avoided.
The article for this week’s CQW is a randomized control trial that enrolled 164 breastfeeding dyads who were 24-72 hours old with newborn weight loss at or above the 75th percentile based on the Newborn Weight Loss Tool (NEWT). What does 75th % mean? An example would be an 8 lb infant born vaginally, who is down 8.3% from birth weight, to 7 lb 6 oz at 48 hours. Not a typical candidate for a newborn who is otherwise nursing well.
Half of the newborns were supplemented with 10 ml of hydrolyzed formula using a syringe after each nursing. The mothers were instructed to stop the supplementation once she felt copious milk production. The other half, the controls, were given the same level of breastfeeding support as the intervention group.
Breastfeeding rates were reported for 1 week, 6 months and 12 months postpartum.
- Infants who received early routine formula supplementation were less likely to be exclusively breastfeeding 1 week, vs infants who did not receive early formula supplementation.
- The 6 month exclusive and any-breastfeeding rates were lower for the formula supplementation group vs the no-supplementation group.
- The 12 month breastfeeding rates were similar between the formula supplementation group vs the no-supplementation group.
- Receiving formula at 1 week postpartum was very strongly associated with low breastfeeding rates at 6 and 12 months.
See the Answer
Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants.
To determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months.
Design, Setting, and Participants
This randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016.
Early Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention.
Main Outcomes and Measures
The study’s primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey.
Eighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%]; P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P = .049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, –12%; 95% CI, –26% to 3%; P = .12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, –18%; 95% CI, –34% to –3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group.
Conclusions and Relevance
In this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation.
The 12 month breastfeeding rates were higher among the no-supplementation group.
Some of you may remember the splash these authors made in 2013 when they published a small randomized trial involving 40 infants at 5% weight loss, where 20 were supplemented with 10ml of formula after each feeding, vs no supplementation. In that study, they surprised the world by reporting that the supplementation group used less formula at 1 week postpartum and had markedly higher exclusive breastfeeding rates at 3 months. Many surmised that giving very small amounts of formula early postpartum prevented excessive weight loss necessitating larger volumes of formula supplementation. One outcome of that study was Similac’s new ‘supplementation’ formula.
Thankfully, this new, more robust study, refutes what they found in 2013, and supports the evidence demonstrating that exclusive breastfeeding postpartum is associated with improved long term breastfeeding success.
In this day and age, why did the research group not use pasteurized donor human milk, the use of which is increasingly common in term and late-preterm hospitalized newborns? I don’t know, but should mention that 2 of the authors disclosed that they are paid consultants for formula manufacturers.