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

Part of paid clinical trials in Corpus Christi, Texas.

Sponsor
Driscoll Children's Hospital
Study ID
NCT07087782
Status
Recruiting
Apply to this trial

Conditions

  • Single-ventricle

Eligibility Criteria

Sex
ALL
Age
0 Months - 6 Months
Healthy Volunteers
Not accepted

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.
  • Standard Nutritional Care — OTHER
    Standard infant formulas (including hydrolyzed formulas) fortification to 24-30 kcal/oz

Study Details

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.

Key Dates

Start date
Jul 30, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Driscoll Children's HospitalCorpus ChristiTexas78411
Sannya Hede, MD
[email protected]
361-694-5000
Erin Richmond, MS, RN, CCRP
[email protected]
3616945978
Sannya Hede, MD (PRINCIPAL_INVESTIGATOR)

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Driscoll Children's Hospital· Corpus Christi, TX

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