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.
Infants with single ventricle physiology who have undergone Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt)
Medically stable and ready for discharge from the hospital
Feeding via oral, nasogastric (NG), or gastrostomy tube
Age < or = 6 months at time of discharge
Preexisting gastrointestinal condition contraindicating formula use (e.g. NEC, short gut, malabsorption)
Contraindication to Fortini (e.g. proven cow's milk protein allergy)
Current enrollment in another interventional feeding or nutrition study
Social circumstances likely to preclude safe outpatient follow up
Parallel
Fortini formula
Other interventionFortini, a commercially available formula providing 30 kcal/oz, is commonly used in older children with failure to thrive or feeding intolerance. It offers the theoretical benefit of providing higher caloric density in a lower volume, which may be advantageous in infants with single ventricle physiology, who often have limited volume tolerance and high metabolic demands.
Standard Nutritional Care
Other interventionStandard infant formulas (including hydrolyzed formulas) fortification to 24-30 kcal/oz
Change in weight-for-age Z-score (WAZ)
Change in weight-for-age Z-score (WAZ) from hospital discharge after Stage 1 surgical palliation to Stage 2 surgical evaluation, which is typically 4-6 months after discharge or between 6-9 months of age
Incidence of feeding intolerance
Incidence of feeding intolerance (e.g., emesis, diarrhea, constipation requiring change in formula)
Daily caloric intake
Average daily caloric intake (kcal/kg/day) during interstage period (4-6 months after hospital discharge)
Unplanned readmissions
Number of unplanned readmissions related to feeding or failure to thrive within the 4-6 months after discharge
Caregiver-reported feeding stress
Caregiver-reported feeding stress (measured via a validated survey/score on a scale of 1-10 where 1 is no stress and 10 is the most stress)
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