NCT04492579

Newborns Supplemented With Gentle-UHT Donor Milk

Neonates Supplemented With Gentle-UHT Donor Human Milk in the First Week of Life

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: LactaLogics, Inc · Industry
• Sex: All
• Age: 4 Days
• Healthy volunteers: Accepted

Summary

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.

Conditions

• Newborns
• Breast Milk Expression

Interventions

Type	Name	Description
OTHER	Gentle-UHT donor human milk supplementation	Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born \>36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.

Timeline

• Start date: 2018-08-03
• Primary completion: 2019-01-31
• Completion: 2020-01-17
• First posted: 2020-07-30
• Last updated: 2020-07-30

Locations

1 site across 1 country: United States