Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology (H-36602)

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

Background
In the United States, about 40,000 births per year are associated with a congenitally malformed heart. Infants with single ventricle physiology (~15 percent of all CHD) face a significant challenge in terms of growth both short and long term, particularly after the first palliative surgery during the inter-stage. Currently, the standard of care is to feed these infants with unfortified human milk or formula until infant is almost at full feeds. Early feeding of fortified human milk has been shown to improve growth in a neonatal population at highest risk for growth failure such as preterm infants.

Purpose and Objective
The primary objective is to evaluate growth velocity (weight velocity [g/kg/day] and weight z-score from 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 throughout the 30 day feeding period following surgical repair or until hospital discharge, whichever comes first. The secondary measures of growth will be the rate of linear growth (cm/week and z-score from WHO growth charts) and incremental rate of head circumference growth (cm/week and z-score from WHO growth charts) over the duration of the initial 6 months of the post-surgical period or prior to the 2nd stage palliation surgery whichever comes first.

For study details see Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology.