Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
Driscoll Children's Hospital
Summary
This study is testing whether a special formula called Fortini, which is a high-calorie, low osmolality formula can help high-risk babies with single ventricle physiology grow better after their initial Stage 1 surgical palliation. These babies often struggle to gain weight, which can lead to more health problems before their next surgery. After their first heart surgery, but prior to discharge, babies will be randomly placed into two groups. One group will get Fortini formula when they leave the hospital, and the other group will get the standard of care high-calorie formula. The primary goal is to see if Fortini helps babies grow better by the time they are ready for their second surgery. The study will also check if the babies tolerate the formula well, how much they eat, how often they are re-admitted to the hospital, and how their caregivers feel about feeding. The babies will be followed for up to 4 months, until they return for their next surgery. About 100 infants are expected to join the study at Driscoll Children's Hospital. This research may help improve nutrition care for infants with complex heart conditions and reduce stress for their families.
Description
Infants with single ventricle physiology are among the highest-risk pediatric cardiac patients, particularly during the interstage period between Stage 1 and Stage 2 surgical palliation. Suboptimal growth during this time is a well-established predictor of increased morbidity, prolonged hospitalization, and adverse surgical outcomes. Despite advances in interstage monitoring and nutritional support, many infants fail to achieve adequate weight gain, and caregiver burden related to complex feeding regimens remains high. Current feeding strategies often require fortification to 24-30 kcal/oz us…