Recruiting

Fortini

Sponsor:

Driscoll Children's Hospital

Code:

NCT07087782

Conditions

Single-ventricle

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Fortini formula

Standard Nutritional Care

Study Details

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.

Conditions

Single-ventricle

Study ID

NCT07087782

Start date

Jul 30, 2025

Status verified date

May, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Fortini Formula

Fortini, a commercially available formula providing 30 kcal/oz

active comparator: Standard nutritional care

Standard infant formulas (including hydrolyzed formulas) fortification to 24-30 kcal/oz

Interventions

Fortini formula

Fortini, a commercially available formula providing 30 kcal/oz, is commonly used in older children with failure to thrive or feeding intolerance. It offers the theoretical benefit of providing higher caloric density in a lower volume, which may be advantageous in infants with single ventricle physiology, who often have limited volume tolerance and high metabolic demands.

Standard Nutritional Care

Standard infant formulas (including hydrolyzed formulas) fortification to 24-30 kcal/oz

Primary outcome measure

  • Change in weight-for-age Z-score (WAZ) [ Time Frame: 4-6 months ]

Central Contacts and Locations

Central contacts

Sannya Hede, MD

361-694-5000sannya.hede@dchstx.org

Erin Richmond

361-694-5978erin.richmond@dchstx.org

Locations

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Sannya Hede, MD

361-694-5000sannya.hede@dchstx.org

Erin Richmond, MS, RN, CCRP

3616945978erin.richmond@dchstx.org

Principal Investigator:

Sannya Hede, MD

More Information

Sponsor

Driscoll Children's Hospital

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Driscoll Children's Hospital on 2026-05-13.