Early Limited Formula for Treating Lactation Concerns (ELF-TLC)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Breastfeeding

Treatments: Other: Early Limited Formula; Other: Standard Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02313181

R40-MC26810

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18 to 72 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
2. Exclusively breastfeeding (has not received any feedings other than breast milk)
3. Infant is 18-72 hours old
4. Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
5. English-speaking mother

Exclusion criteria

1. Mothers or infants for whom breastfeeding is not recommended by the clinical team
2. Mothers who have already begun to produce mature breast milk
3. Any formula or water feeding prior to enrollment
4. Infants who have already lost ≥10% of their birth weight
5. Family with no active telephone number (home or cellular)
6. Plan for infant adoption or foster care
7. Mothers <18 years of age
8. Infant receiving scoring for Narcotic Abstinence Syndrome -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 2 patient groups

Early Limited Formula

Experimental group

Description:

10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production

Treatment:

Other: Early Limited Formula

Standard Care

Other group

Description:

Continue exclusive breastfeeding unless otherwise instructed by a health care provider

Treatment:

Other: Standard Care