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

RecruitingNAAges 0 Months - 6 MonthsAllDriscoll Children's Hospital
NCT07087782 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Fortini formula
  • Standard Nutritional Care
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Where

1 site
Driscoll Children's Hospital
Corpus Christi, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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