Starting Fortini after the first heart surgery to help infants with single-ventricle defects grow better
Official title: Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
Run by Driscoll Children's Hospital · NCT07087782 · Data updated 2026-11-12
This trial will see if giving Fortini, a high-calorie low-osmolality formula, at hospital discharge helps infants with single-ventricle heart defects gain more weight before their next surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Months to 6 Months |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Driscoll Children's Hospital Academic / other |
| Locations | 1 site (Corpus Christi, Texas) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07087782 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants ≤6 months with single-ventricle physiology who are medically stable and ready for discharge after Stage 1 surgery and who feed orally or via NG/gastrostomy tube, with a parent or guardian able to consent.
✕Probably not a fit
Infants with gastrointestinal contraindications (e.g., NEC, short gut, malabsorption), proven cow's milk protein allergy, current enrollment in another interventional nutrition study, or those unable to complete outpatient follow-up are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Infants who have undergone Stage 1 palliation for single-ventricle physiology will be randomly assigned at discharge to receive either Fortini (30 kcal/oz) or the current standard high-calorie formula. The study follows infants through the interstage period up to their Stage 2 surgery (about 4 months) and measures weight gain as the primary outcome. Secondary outcomes include feeding tolerance, intake volumes, hospital readmissions, and caregiver-reported feeding burden. About 100 infants will be enrolled at a single center (Driscoll Children's Hospital) to determine whether early Fortini initiation improves growth without increasing adverse effects.
Why it matters
Potential benefit: If successful, Fortini could help these infants gain weight more effectively between surgeries and potentially reduce complications or readmissions before the second operation.
How similar studies have gone: Retrospective reports and clinical experience suggest that increasing caloric density can improve weight gain, but Fortini has not been tested prospectively in infants under 6 months with single-ventricle physiology.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
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Driscoll Children's Hospital
Corpus Christi, Texas, United States Recruiting
Study contacts
- Study coordinator: Sannya Hede, MD
- Email: sannya.hede@dchstx.org
- Phone: 361-694-5000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.