Purpose

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

IRB Number
20150779HU
NCT Number
NCT02860702
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Principal Investigator
Cynthia Blanco

Diana Anzueto Guerra
210-567-5225
anzuetod@uthscsa.edu

Dauren Alimbetov
210-567-5230
alimbetov@uthscsa.edu



Eligibility

Eligible Ages
Under7 Days
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. 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.
    2. Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment
    3. Parent(s) willing to sign informed consent.
    4. Parent(s) willing to comply with study follow-up procedures.
    5. Require surgical palliation within the first 1 month of life.

Exclusion Criteria

    1. Term infants >7 days old at the time of diagnosis.
    2. <37 weeks gestation
    3. Infants requiring cardio-pulmonary resuscitation prior to surgical repair.
    4. 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.

    5. Major congenital abnormalities that could significantly affect survival such as:

      1. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
      2. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few)
      3. 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))
      4. Heterotaxia
      5. Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects
    6. Evidence of intracerebral hemorrhage (IVH) ≥ Grade 3
    7. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival.
    8. Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively
    9. 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Investigator)
Condition
  • Congenital Heart Defect

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    Exclusive Human Milk

    		All infants randomized to this arm will receive exclusive human milk diet with addition of human milk derived fortifier from birth to 30 days post initiation of feedings after initial palliative cardiac surgery
  • Other: Human Milk Derived Fortifier

    Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm

    • Active Comparator

    Human/Bovine Milk

    		All infants randomized to this arm will receive exclusive human milk diet prior to randomization and will use either human and/or bovine milk and fortifier per the institution's standard practice 30 days post initiation of feedings after initial palliative cardiac surgery
  • Other: Human/Bovine Milk

    Bovine milk derived fortification

    Other names:

    • Human/Formula Milk

    •