NCT02313181

Early Limited Formula for Treating Lactation Concerns

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Hours – 72 Hours
• Healthy volunteers: Accepted

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.

Conditions

• Breastfeeding

Interventions

Type	Name	Description
OTHER	Early Limited Formula	10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
OTHER	Standard Care	Continue exclusive breastfeeding unless otherwise directed by a health care provider

Timeline

• Start date: 2015-01-07
• Primary completion: 2017-03-30
• Completion: 2017-10-01
• First posted: 2014-12-09
• Last updated: 2018-05-03

Locations

2 sites across 1 country: United States