Limited Amount of Formula May Facilitate Breastfeeding: Randomized, Controlled Trial to Compare Standard Clinical Practice versus Limited Supplemental Feeding

Abstract

ObjectivesBreastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless, breastfeeding rates remain low despite public health efforts. Our study aims to investigate the effect of controlled limited formula usage during birth hospitalisation on breastfeeding, using the primary hypothesis that early limited formula feeds in infants with early weight loss will not adversely affect the rate of exclusive or any breastfeeding as measured at discharge, 3 and 6 months of age.Material and MethodsWe randomly assigned 104 healthy term infants, 24 to 48 hours old, with ≥ 5% loss of birth weight to controlled limited formula (CLF) intervention (10 ml formula by syringe after each breastfeeding, discontinued at onset of lactation) or control group (standard approach, SA). Groups were compared for demographic data and breastfeeding rates at discharge, 3 months and 6 months of age (p-values adjusted for multiple testing).ResultsFifty newborns were analysed in CLF and 50 in SA group. There were no differences in demographic data or clinical characteristics between groups. We found no evidence of difference between treatment groups in the rates of exclusive as well as any breastfeeding at discharge (p-value 0.2 and >0.99 respectively), 3 months (p-value 0.12 and 0.10) and 6 months of infants’ age (p-value 0.45 and 0.34 respectively). The percentage weight loss during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in SA group, p = 0.002).ConclusionThe study shows that controlled limited formula use does not have an adverse effect on rates of breastfeeding in the short and long term. Larger studies are needed to confirm a possible potential in controlled limited formula use to support establishing breastfeeding and to help to improve the rates of breastfeeding overall.Trial RegistrationISRCTN registry ISRCTN61915183

Fatal Hypernatremic Dehydration in a Term Exclusively Breastfed Newborn

“…The effects of judicious supplementation with 10 mL formula or banked human milk only after on-demand breastfeeding were tested in a total of five randomized controlled trials for weight loss of ≥5% or ≥75th percentile weight loss on the NEWT and all five found no reduction in any and exclusive breastfeeding rates at 3 months [ 69 , 70 , 71 , 72 , 73 ]. One study found no readmissions occurred in supplemented newborns and that supplementation had no effect on the infant gut microbiome [ 71 ].…”

National Prevalence of Donor Milk Use Among Level 1 Nurseries

“…The impact of early donor milk use on lactation outcomes should also be considered. Although authors of observational studies suggest that early formula use is associated with shorter duration of any breastfeeding, [26][27][28] authors of randomized controlled trials of early, limited formula found no negative impact on breastfeeding rates at 1, 3, and 6 months postpartum, 23,29 suggesting that it may be the supplementation protocol, not the supplement, that influences breastfeeding outcomes. In our study, we found that donor milk is typically provided as a supplement to the mother' s own milk for a specific medical indication, suggesting that interference with breastfeeding in the first days after birth may not be substantial.…”

Improved breastfeeding duration with Baby Friendly Hospital Initiative implementation in a diverse and underserved population

“…[11][12][13][14][25][26][27] However, others found no effect of formula supplementation on breastfeeding outcomes. [28][29][30] It is hypothesized that formula supplementation may interfere with the physiology of milk production because of an interruption of the natural balance between supply and demand. 25 The literature on the effect of inpatient pacifier use on breastfeeding duration is mixed.…”

“…Avoiding inpatient formula supplementation for nonmedical reasons has been associated with longer exclusive and partial breastfeeding duration in the literature . However, others found no effect of formula supplementation on breastfeeding outcomes . It is hypothesized that formula supplementation may interfere with the physiology of milk production because of an interruption of the natural balance between supply and demand …”