Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology (NCT02860702) | Clinical Trial Compass
CompletedNot Applicable
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
United States16 participantsStarted 2016-07
Plain-language 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).
Who can participate
Age range1 Day – 7 Days
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
growth velocity
Timeframe: 30 days
2
growth velocity
Timeframe: 30 days
Trial details
NCT IDNCT02860702
SponsorThe University of Texas Health Science Center at San Antonio
✕. 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))