Early Use of Fortini Formula to Improve Growth and Feeding Outcomes in Infants With Single Ventricle Heart Condition

What this Trial Is About

This research evaluates whether Fortini, a high-calorie, low osmolality formula, can help infants with single ventricle physiology grow better after their first heart surgery Stage 1 surgical palliation. These infants often have trouble gaining weight, which can lead to more health problems before their next surgery. The study aims to improve nutrition care and reduce caregiver stress for these high-risk babies during the critical interstage period. Babies will be randomly assigned to one of two groups after their initial heart surgery but before hospital discharge. One group will receive Fortini formula, which provides 30 kcaloz with lower volume, while the other group will receive standard high-calorie fortified infant formulas 24-30 kcaloz. The infants will be followed until their next surgery, about 4 months later, to compare growth and feeding outcomes between the two groups. Participants will be monitored through weight measurements, feeding tolerance checks, daily calorie intake tracking, hospital readmission records, and caregiver feedback about feeding stress. The main measure is the change in weight-for-age Z-score by 4 to 6 months. Safety and caregiver experience will also be assessed. The total study duration for each infant is up to 4 months, with about 100 infants expected to join at Driscoll Childrens Hospital.

Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology