Clinical Trial – Exclusive Human Milk Feeding in Infants with Single Ventricle Physiology – Congenital Heart Disease

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. 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 neurodevelopment outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis. In brief, all patients will receive exclusive maternal human milk or donor human milk prior to randomization.

No drugs. The intervention measure is human milk.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

 Contacts:

Contact: Amy Piacentino, BScN CRAII 310-748-7237 APiacentino@prolacta.com
Contact: Robin Tragus, RN 2104888054 tragus@uthscsa.edu
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