Last updated on October 2018

Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Congenital Heart Defect
  • Age: - 1 Years
  • Gender: Male or Female

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:
  6. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
  7. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few)
  8. 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))
  9. Heterotaxia
  10. Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects
  11. Evidence of intracerebral hemorrhage (IVH) Grade 3
  12. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival.
  13. Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively
  14. 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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