Effect of Early Limited Formula on Breastfeeding Duration in the First Year of Life

Abstract

IMPORTANCEBreastfeeding 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.OBJECTIVE 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 PARTICIPANTSThis 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.INTERVENTIONS 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 MEASURESThe 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.RESULTS 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 RELEVANCEIn 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 differential role of practical and emotional support in infant feeding experience in the UK

“…the former is potentially more likely in light of evidence that limited early formula feeding is not correlated with stopping [48].…”

“…Our measures of support were intended to capture support received in the first few weeks post birth, therefore, it is interesting that the impact of reported allofeeding extends across the 20 months analysed. This may indicate the retrospective reporting of support was influenced by current experience, or that the early introduction of bottled milk (either expressed or formula) alongside breastfeeding always increases the likelihood of stopping from then on; the former is potentially more likely in light of evidence that limited early formula feeding is not correlated with stopping [52].…”

Evidence-Based Updates on the First Week of Exclusive Breastfeeding Among Infants ≥35 Weeks

“…116 In a subsequent larger study (N = 164), early limited supplementation did not affect overall breastfeeding at 1 or 6 months but slightly increased rates of formula use at 1 month (36.7% vs 22.4%; P = .08), 105 decreased breastfeeding at 12 months (30% vs 48%; risk difference 218% [CI 234% to 23%]), and shortened the time to breastfeeding cessation (hazard ratio 0.65; 95% CI 0.43 to 0.97). 117 Because evidence continues to accrue that supplementation in the first days after birth has major health risks, 103,106 judicious use of supplementation is a critical goal, with a return to exclusivity whenever possible. If supplementation is indicated (Fig 1), options in order of preference are (1) expressed milk from the infant's own mother, 4 (2) PDHM, and (3) commercial infant formulas.…”

Use of donor human milk in nonhospitalized infants: An infant growth study

“…When used in the context of optimal lactation support, DHM use in neonatal intensive care unit (NICU) can support maternal breastfeeding (Adhisivam et al, 2017; Kantorowska et al, 2016; Wilson et al, 2018), whereas the early introduction of IF is correlated with early breastfeeding cessation (Chantry, Dewey, Peerson, Wagner, & Nommsen‐Rivers, 2014; McCoy & Heggie, 2020). Two randomized controlled trials evaluated early, controlled supplementation with IF or DHM for newborns with significant weight loss, finding neither form of supplementation‐influenced breastfeeding duration (Flaherman, Cabana, McCulloch, & Paul, 2019; Kair, Flaherman, & Colaizy, 2019).…”