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Newborns Supplemented With Gentle-UHT Donor Milk

NCT04492579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-30

No results posted yet for this study

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.

Conditions

  • Newborns
  • Breast Milk Expression

Interventions

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.

Sponsors & Collaborators

  • Renown Regional Medical Center

    collaborator OTHER

  • LactaLogics, Inc

    lead INDUSTRY

Principal Investigators

  • Rebecca Perry, MD · Renown Regional Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
4 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2019-01-31
Completion
2020-01-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492579 on ClinicalTrials.gov