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Lay Description

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).

Category

  • Diabetes
  • Heart, Vascular and Blood
IRB Number
20170305HU
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

Eligible Ages
Under 7 Days
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Exclusion Criteria

Study Design

Arm Groups

Study Contact

Regulatory Point of Contact
Jasmine Rodriguez
(210) 358-3200
rodriguezj33@uthscsa.edu

Principal Investigator
Fozia Ali