RecruitingNot ApplicableNCT07087782

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

Sponsor

Driscoll Children's Hospital

Enrollment

100 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Single Ventricle

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.

Eligibility

Min Age: 0 MonthsMax Age: 6 Months

Inclusion Criteria5

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
Parent or legal guardian able to provide informed consent

Exclusion Criteria4

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

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Interventions

OTHERFortini formula

Fortini, 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.

OTHERStandard Nutritional Care

Standard infant formulas (including hydrolyzed formulas) fortification to 24-30 kcal/oz