Newborns Supplemented With Gentle-UHT Donor Milk

NCT ID: NCT04492579

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2020-01-17

Brief Summary

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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.

Detailed Description

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Conditions

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Newborns Breast Milk Expression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gentle-UHT donor human milk supplementation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Renown Regional Medical Center

OTHER

Sponsor Role collaborator

LactaLogics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Perry, MD

Role: PRINCIPAL_INVESTIGATOR

Renown Regional Medical Center

Locations

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LactaLogics, Inc.

Port Saint Lucie, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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5642622173

Identifier Type: -

Identifier Source: org_study_id

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