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NCT04492579 Clinical Trial

Newborns Supplemented With Gentle-UHT Donor Milk

Breast Milk Expression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04492579
Other study ID # 5642622173
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2018
Est. completion date January 17, 2020

Study information
Verified date July 2020
Source LactaLogics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date January 17, 2020
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States LactaLogics, Inc. Port Saint Lucie Florida

Sponsors (2)
Lead Sponsor Collaborator
LactaLogics, Inc Renown Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight gain Average weights compared to WHO data 8-9 days of life
Secondary Exclusive human milk diet Rates of infants still on an exclusive human milk diet 8-9 days of life
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