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Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

NCT02860702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-09-26

No results posted yet for this study

Summary

A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following, surgical repair. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.

The study hypothesis is that infants fed an exclusive human milk diet will have short and long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).

Conditions

  • Congenital Heart Defect

Interventions

OTHER

Human Milk Derived Fortifier

Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm

OTHER

Human/Bovine Milk

Bovine milk derived fortification

Sponsors & Collaborators

  • Prolacta Bioscience

    collaborator INDUSTRY

  • Baylor College of Medicine

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • University of Oklahoma

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Cook Children's Medical Center

    collaborator OTHER

  • Children's Hospital of Orange County

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Cynthia Blanco, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-12-31
Completion
2022-10-06

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02860702 on ClinicalTrials.gov