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

NCT07087782 | Not Yet Recruiting

• 1 other identifier: DCHIRB-FY2025-72
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• PRIMARY ENDPOINT

  Change in weight-for-age Z-score (WAZ) from hospital discharge after Stage 1 surgical palliation to Stage 2 surgical evaluation, which is typically 4-6 months after discharge or between 6-9 months of age

  4-6 months

Secondary Outcomes (5)

• 2.1

  4-6 months

• 2.2

  4-6 months

• 2.3

  4-6 months

• 2.4

  4-6 months

• 2.5

  4-6 months

Study Arms (2)

Fortini Formula

EXPERIMENTAL

Fortini, a commercially available formula providing 30 kcal/oz

Other: Fortini formula

Standard nutritional care

ACTIVE COMPARATOR

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

Other: Standard Nutritional Care

Interventions

Fortini formula OTHER

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.

Fortini Formula

Standard Nutritional Care OTHER

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

Standard nutritional care

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with single ventricle physiology who have undergone Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt)
• Medically stable and ready for discharge from the hospital
• Feeding via oral, nasogastric (NG), or gastrostomy tube
• Age \< or = 6 months at time of discharge
• Parent or legal guardian able to provide informed consent

You may not qualify if:

• Preexisting gastrointestinal condition contraindicating formula use (e.g. NEC, short gut, malabsorption)
• Contraindication to Fortini (e.g. proven cow's milk protein allergy)
• Current enrollment in another interventional feeding or nutrition study
• Social circumstances likely to preclude safe outpatient follow up

Sponsors & Collaborators

• Driscoll Children's Hospital: lead

MeSH Terms

Conditions

Univentricular Heart

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sannya Hede, MD

CONTACT

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

Erin Richmond

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 28, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 28, 2025

Record last verified: 2025-07