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Human Milk for Congenital Gastrointestinal Disorders

NCT02567292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-08-28

No results posted yet for this study

Summary

This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).

Conditions

  • Congenital Gastrointestinal Disorders

Interventions

OTHER

Human Milk

Participants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants \<37 weeks PMA and/or or weight \<2,200g or PBCLN-002 for infants \>37 weeks PMA and/or weight \>2,200g)

Sponsors & Collaborators

  • Chatham Valley Foundation

    collaborator UNKNOWN

  • Prolacta Bioscience

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Heidi Karpen, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Minute
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2022-01-18
Completion
2022-01-18

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 NCT02567292 on ClinicalTrials.gov