Newborns Supplemented With Gentle-UHT Donor Milk

Completed · Not applicable

Conditions studied: Newborns, Breast Milk Expression

In brief

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.

Key facts

Study ID

NCT04492579

Run by

LactaLogics, Inc

People needed

31

Starts

2018-08-03

Expected to finish

2020-01-17

Last updated by the study team

2020-07-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Gestational age >36 weeks
• Exclusively fed human milk
• Age <96 hours (4 days)

You may not qualify if…

• Previous admittance to the neonatal intensive care unit
• Supplementation of any formula

Where it is running

• LactaLogics, Inc. — Port Saint Lucie, Florida, United States

Full record on ClinicalTrials.gov

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