Home › Univentricular Heart › NCT07087782

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

Who can join

0 Months – 6 Months · All sexes

Inclusion Criteria:

1. Infants with single ventricle physiology who have undergone Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt)
2. Medically stable and ready for discharge from the hospital
3. Feeding via oral, nasogastric (NG), or gastrostomy tube
4. Age \< or = 6 months at time of discharge
5. Parent or legal guardian able to provide informed consent

Exclusion Criteria:

1. Preexisting gastrointestinal condition contraindicating formula use (e.g. NEC, short gut, malabsorption)
2. Contraindication to Fortini (e.g. proven cow's milk protein allergy)
3. Current enrollment in another interventional feeding or nutrition study
4. Social circumstances likely to preclude safe outpatient follow up

About the study

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.

What is being tested

• Fortini formula (other)
• Standard Nutritional Care (other)

Sponsor: Driscoll Children's Hospital · Participants: 100 · Started: Jul 30, 2025

Contact the study team

• Sannya Hede, MD · Phone: 361-694-5000
• Erin Richmond · Phone: 361-694-5978

Official record on ClinicalTrials.gov — NCT07087782

Locations in the U.S.

Conditions

• Univentricular Heart

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.