NCT07087782 Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
| NCT ID | NCT07087782 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Driscoll Children's Hospital |
| Condition | Single-ventricle |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-30 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07087782 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 6 Months, studying Single-ventricle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07087782 currently recruiting?
Yes, NCT07087782 is actively recruiting participants. Contact the research team at sannya.hede@dchstx.org for enrollment information.
Where is the NCT07087782 trial being conducted?
This trial is being conducted at Corpus Christi, United States.
Who is sponsoring the NCT07087782 clinical trial?
NCT07087782 is sponsored by Driscoll Children's Hospital. The trial plans to enroll 100 participants.