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Completed

NCT Number: NCT04492579

Newborns Supplemented With Gentle-UHT Donor Milk

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.

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Key information

Conditions

Newborns Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

Up to 4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LactaLogics, Inc.

Port Saint Lucie, Florida, 34952, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gentle-UHT donor human milk supplementation

Other

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.

Primary outcomes

  1. Weight gain

    Time frame: 8-9 days of life

    Average weights compared to WHO data

Secondary outcomes

  1. Exclusive human milk diet

    Time frame: 8-9 days of life

    Rates of infants still on an exclusive human milk diet

Sponsors and collaborators

Lead sponsor

LactaLogics, Inc

Industry

Collaborators

  • Renown Regional Medical Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 30, 2020
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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