Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
Recruiting
N/A
Interventional Study
Single-ventricle
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 0 Months – 6 Months
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 100 (estimated)
- Sponsor
- Driscoll Children's Hospital · Other
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About This Trial
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, …
Trial Locations
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Eligibility Criteria
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 tim…
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