Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
Condition: Congenital Heart Defect
MeSH terms: Heart Defects, Congenital; Univentricular Heart
Study type: Interventional

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).
    

Detailed description: 
      This is a single blinded (physician investigator), randomized, controlled trial to evaluate
      growth velocity and clinical outcomes in infants with single ventricle physiology fed an
      exclusive human milk diet during their initial hospitalization after birth and through the 30
      days post-surgical repair feeding period or hospital discharge, whichever comes first.

      Subjects will be randomized to one of two groups at birth or immediately following diagnosis
      if prenatal care was not obtained prior to birth. Parents who decline participation by their
      infants in the study will be asked to consent to data gathering on their infants who will be
      treated and fed per institutional practice. The data on these individuals will be summarized
      and evaluated descriptively in comparison with the actual trial results.

      All patients will receive exclusive maternal human milk or donor human milk prior to
      randomization. Once randomized, patients in Group One will receive an exclusive human milk
      diet prior to the surgery and throughout the 30-day feeding period following surgical repair
      or until hospital discharge, whichever comes first. Day 1 is defined as the day of the first
      enteral feed post-surgery. Patients in Group Two (Control Group) will receive maternal human
      milk or formula or donor human milk (per standard of care at each hospital) in the
      pre-surgical period. In the post-surgical period the control group will receive human milk or
      formula, as per feeding algorithm The primary objective of this study is to evaluate growth
      velocity (weight velocity [g/kg/day] and weight z-score from World Health Organization (WHO)
      growth charts) at 30 days after the initiation of feed post-surgery for infants with single
      ventricle physiology who are fed an exclusive human milk diet from birth through the 30 day
      feeding period following surgical repair or until hospital discharge, whichever comes first.
    

Intervention name(s): Human Milk Derived Fortifier; Human/Bovine Milk
Intervention type(s): Other; Other
Intervention description(s): Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm; Bovine milk derived fortification
Other intervention name(s): Human/Formula Milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Single Ventricle; Congenital Heart Defect