Newborns Supplemented With Gentle-UHT Donor Milk

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

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.

Study Overview

• Status: Completed
• Conditions: Newborns; Breast Milk Expression
• Intervention / Treatment: Other: Gentle-UHT donor human milk supplementation

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • LactaLogics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain	Average weights compared to WHO data	8-9 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive human milk diet	Rates of infants still on an exclusive human milk diet	8-9 days of life

Collaborators and Investigators

• Sponsor: LactaLogics, Inc
• Collaborators: Renown Regional Medical Center
• Investigators: Principal Investigator: Rebecca Perry, MD, Renown Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 5642622173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No