Early Limited Formula for Treating Lactation Concerns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 328
- Locations
- 4
- Primary Endpoint
- Length of breastfeeding duration
Study Overview
Brief Summary
This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Hours to 72 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
- •Exclusively breastfeeding (has not received any feedings other than breast milk)
- •Infant is 18-72 hours old
- •Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
- •English-speaking mother
Exclusion Criteria
- •Mothers or infants for whom breastfeeding is not recommended by the clinical team
- •Mothers who have already begun to produce mature breast milk
- •Any formula or water feeding prior to enrollment
- •Infants who have already lost ≥10% of their birth weight
- •Family with no active telephone number (home or cellular)
- •Plan for infant adoption or foster care
- •Mothers <18 years of age
- •Infant receiving scoring for Narcotic Abstinence Syndrome -
Arms & Interventions
Early Limited Formula
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
Intervention: Early Limited Formula (Other)
Standard Care
Continue exclusive breastfeeding unless otherwise instructed by a health care provider
Intervention: Standard Care (Other)
Outcomes
Primary Outcomes
Length of breastfeeding duration
Time Frame: 12 months
The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding
Secondary Outcomes
- State Trait Anxiety Inventory(1 month)
- Health care utilization(1 month)
- Formula use(6 months)
Investigators
Valerie Flaherman
Associate Professor of Pediatrics and Epidemiology and Biostatistics
University of California, San Francisco