Effect of Early Limited Formula on Duration and Exclusivity of Breastfeeding in At-Risk Infants: An RCT

Abstract

BACKGROUND AND OBJECTIVES: Recent public health efforts focus on reducing formula use for breastfed infants during the birth hospitalization. No previous randomized trials report the effects of brief early formula use. The objective of the study was to determine if small formula volumes before the onset of mature milk production might reduce formula use at 1 week and improve breastfeeding at 3 months for newborns at risk for breastfeeding problems. METHODS: We randomly assigned 40 exclusively breastfeeding term infants, 24 to 48 hours old, who had lost ≥5% birth weight to early limited formula (ELF) intervention (10 mL formula by syringe after each breastfeeding and discontinued when mature milk production began) or control (continued exclusive breastfeeding). Our outcomes were breastfeeding and formula use at 1 week and 1, 2, and 3 months. RESULTS: Among infants randomly assigned to ELF during the birth hospitalization, 2 (10%) of 20 used formula at 1 week of age, compared with 9 (47%) of 19 control infants assigned during the birth hospitalization to continue exclusive breastfeeding (P = .01). At 3 months, 15 (79%) of 19 infants assigned to ELF during the birth hospitalization were breastfeeding exclusively, compared with 8 (42%) of 19 controls (P = .02). CONCLUSIONS: Early limited formula may reduce longer-term formula use at 1 week and increase breastfeeding at 3 months for some infants. ELF may be a successful temporary coping strategy for mothers to support breastfeeding newborns with early weight loss. ELF has the potential for increasing rates of longer-term breastfeeding without supplementation based on findings from this RCT.

In-Hospital Formula Use Increases Early Breastfeeding Cessation Among First-Time Mothers Intending to Exclusively Breastfeed

“…32 We believe there may be issues with the appropriateness of the control intervention in the latter study but agree that there is a need to identify infants who truly need short-term formula use and how to best preserve breastfeeding.…”

Breastfeeding Continuation Among Late Preterm Infants: Barriers, Facilitators, and Any Association With NICU Admission?

“…However, the barriers are broad, and future prospective research aimed at further characterizing these barriers among late preterm dyads could be helpful, as could trials testing specific interventions aimed at overcoming these barriers in this population of mother-infant dyads; such interventions could include nipple shields, 26 hand expression, 27,28 and short-term donor milk or formula supplementation. 29,30 Our study benefited from the rigorous PRAMS methods and a sufficiently large sample size to allow for multivariable logistic regression modeling to take into account multiple confounding variables. We were limited by the fact that our participants were from 3 states (2 in the (13) 87 (18) School/work 149 (16) 66 (12) 82 (20) Household duties 146 (13) 74 (14) 72 (12) Right time 114 (10) 57 (11) 57 (10) Jaundice 103 (10) 40 (8) 62 (11) Infant not gaining weight 117 (9) 58 (11) 59 (7) Needed someone else to feed infant 113 (8) 51 (5) 62 (9) Mom sick 80 (8) 43 (6) 36 (9) Infant sick 37 (5) 23 (7) 13 (3) Data are presented as the total number of mothers in each category who answered yes to the item (mothers could select any number of reasons) and the percentage of the total in each category, weighted for nonresponse, noncoverage, and deliberate oversampling.…”

Social and Public Health Perspectives of Promotion of Breastfeeding

“…In many cases, formula use can be compatible with breastfeeding, and, in some cases, it may be true that judicious use of formula can support and even extend breastfeeding duration. 9 …”