Newborns Supplemented With Gentle-UHT Donor Milk

Not Applicable

Completed

• Conditions: Breast Milk Expression; Newborns

• Registration Number: NCT04492579
• Lead Sponsor: LactaLogics, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-03
• Primary Completion: 2019-01-31
• Study Completion: 2020-01-17
• Status Verified: 2020-07
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weight gain	8-9 days of life	Average weights compared to WHO data

Secondary Outcome Measures

Name	Time	Method
Exclusive human milk diet	8-9 days of life	Rates of infants still on an exclusive human milk diet

Trial Locations

Locations (1)

LactaLogics, Inc.; 🇺🇸 Port Saint Lucie, Florida, United States