Newborns Supplemented With Gentle-UHT Donor Milk

Sponsor

LactaLogics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT04492579

Collaborator

Renown Regional Medical Center (Other)

Enrollment

Location

Arm

17.5

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newborns Breast Milk Expression	Other: Gentle-UHT donor human milk supplementation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 3, 2018

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supplementation of Gentle-UHT donor milk Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers.	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.

Arm

Intervention/Treatment

Experimental: Supplementation of Gentle-UHT donor milk

Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers.

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.

Outcome Measures

Primary Outcome Measures

Weight gain [8-9 days of life]
Average weights compared to WHO data

Secondary Outcome Measures

Exclusive human milk diet [8-9 days of life]
Rates of infants still on an exclusive human milk diet

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 4 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LactaLogics, Inc.	Port Saint Lucie	Florida	United States	34952

Sponsors and Collaborators

LactaLogics, Inc
Renown Regional Medical Center

Investigators

Principal Investigator: Rebecca Perry, MD, Renown Regional Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LactaLogics, Inc

ClinicalTrials.gov Identifier:

NCT04492579

Other Study ID Numbers:

5642622173

First Posted:

Jul 30, 2020

Last Update Posted:

Jul 30, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 30, 2020