Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

Completed · Not applicable

Conditions studied: Congenital Heart Defect

In brief

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).

Key facts

Study ID

NCT02860702

Run by

The University of Texas Health Science Center at San Antonio

People needed

16

Starts

2016-07-01

Expected to finish

2022-10-06

Last updated by the study team

2023-09-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Term infants (≥37 and 0/7 weeks gestational age) ≤ 7 days old with a diagnosis of single ventricle physiology who are thought to require a single ventricle repair at the time of enrollment.
• Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment
• Parent(s) willing to sign informed consent.
• Parent(s) willing to comply with study follow-up procedures.
• Require surgical palliation within the first 1 month of life.

You may not qualify if…

• Term infants >7 days old at the time of diagnosis.
• <37 weeks gestation
• Infants requiring cardio-pulmonary resuscitation prior to surgical repair.
• Outborn infants who received enteral nutrition at the other institution prior to surgical repair. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded.
• Major congenital abnormalities that could significantly affect survival such as:
• Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
• Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few)
• Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, Central Nervous System (CNS) malformations: Arnold Chiari, myelomeningoceles, hydranencephaly, schizencephaly, holoprosencephaly))
• Heterotaxia
• Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects
• Evidence of intracerebral hemorrhage (IVH) ≥ Grade 3
• Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival.
• Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively
• Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 30 day feeding period after surgical repair or hospital discharge, whichever comes first.

Where it is running

• Loma Linda University — Loma Linda, California, United States
• Los Angeles Children's Hospital — Los Angeles, California, United States
• Children's Hospital Orange County — Orange, California, United States
• University of Florida Children's Hospital — Gainesville, Florida, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Columbia University — New York, New York, United States
• Cincinatti Children's Hospital Medical Center — Cincinnati, Ohio, United States
• OU Children's Hospital at OU Medical Center — Oklahoma City, Oklahoma, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cook Children's Medical — Fort Worth, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• University Health System — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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