NCT04492579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 23, 2020

Last Update Submit

July 29, 2020

Conditions

NewbornsBreast Milk Expression

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    Average weights compared to WHO data

    8-9 days of life

Secondary Outcomes (1)

  • Exclusive human milk diet

    8-9 days of life

Study Arms (1)

Supplementation of Gentle-UHT donor milk

EXPERIMENTAL

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

Interventions

Gentle-UHT donor human milk supplementationOTHER

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.

Supplementation of Gentle-UHT donor milk

Eligibility Criteria

AgeUp to 4 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LactaLogics, Inc.

Port Saint Lucie, Florida, 34952, United States

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Rebecca Perry, MD

    Renown Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 30, 2020

Study Start

August 3, 2018

Primary Completion

January 31, 2019

Study Completion

January 17, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)