Office of Epidemiology and Research, Division of Research

Advancing Applied MCH Research

The Early Limited Formula Study

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Project Number: R40 MC 26820
Grantee: UCSF
Department/Center: Pediatrics
Project Date: 4/1/2014

Final Report


Principal Investigator

Valerie Flaherman, MD, MPH
Assistant Professor 3333 California Street
Box 0503, Suite 250
San Francisco, CA  94143-0503
Phone: 415-502-6266


  • Women/Maternal
  • Perinatal/Infancy (0-12 months)


Rapid newborn weight loss, common during the birth hospitalization, is associated with an increased risk of breastfeeding cessation and can cause morbidity for newborns and mothers leading to increased healthcare utilization. To ameliorate these problems we propose the Early Limited Formula (ELF) Study, which will compare two different feeding strategies for exclusively breastfeeding newborns 24-48 hours old experiencing rapid weight loss. Currently, guidelines recommend that such babies should continue exclusive breastfeeding. While these well-intended guidelines were designed to increase breastfeeding rates from birth through 1 year, some unintended consequences have arisen for babies and mothers. Hospitals adhering to these guidelines risk causing morbidity for the 21% of mother-infant pairs that are experiencing rapid newborn weight loss. Hospitals not following these guidelines have no evidence-based protocols for formula use, and the absence of such protocols can lead to haphazard formula use without guidance regarding the volume, frequency and duration of formula given. The overall goal of the ELF Study is to examine whether a novel feeding strategy can improve breastfeeding duration among newborns with rapid early weight loss. We will also examine the effect of ELF on infant and maternal morbidity and on health care utilization and maternal satisfaction with quality of care, which may both be affected by morbidity. To achieve these goals, we plan to enroll 164 mother-infant pairs in a multi-center, randomized, controlled trial to test the effect of the use of early limited formula (ELF), 10cc of formula after each breastfeeding prior to the onset of mature milk production, discontinued at the onset of mature milk. This strategy will be compared with routine hospital care. Our primary outcome will be the rate of any breastfeeding at 6 months, which is Healthy People 2020 goal MICH 21.2. Our design will also examine the effects of ELF on total formula use, newborn weight nadir, infant morbidity, maternal anxiety, health care utilization and satisfaction with the quality of hospital care using data obtained in person at enrollment and by phone at 1 week and 1, 3, 6 and 12 months. We will also examine the effect of ELF on rates of breastfeeding without formula at 3 months among low-income mothers, a population at increased risk of very early breastfeeding discontinuation. By evaluating whether ELF improves breastfeeding duration, the ELF study will directly address the Maternal Child Health Bureau’s Strategic Issue #4, Promoting the Healthy Development of MCH Populations. By examining whether ELF improves maternal satisfaction with care during hospitalization, we will address Strategic Issue #3, Services to Improve Quality of Care. In addition, by determining whether ELF improves breastfeeding among mothers who are low- income, we will also address Strategic Issue #2, Eliminating Health Disparities. It is possible that for some subgroups of newborns, the use of early, limited amounts of formula, discontinued at the onset of mature milk production, could improve breastfeeding rates while reducing infantmorbidity, maternal anxiety and overall health care utilization.




Breastfeeding, Health Care Utilization, Infant Illness & Hospitalization, Mental Health & Wellbeing, Nutrition & Diet, Parenting, Postpartum

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