NCT04572581

Donor Breast Milk and Breastfeeding Rates

Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

Detailed description

In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Conditions

• Breastfeeding, Exclusive
• Breastfeeding

Interventions

Type	Name	Description
OTHER	Donor Breast Milk	Donor breast milk will be given to the newborn if supplementation is required

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-06-26
• Completion: 2022-08-15
• First posted: 2020-10-01
• Last updated: 2022-09-01

Locations

2 sites across 1 country: United States