Actively Recruiting
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
Led by Driscoll Children's Hospital · Updated on 2026-05-13
100
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with single ventricle physiology who have had Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt)
- Medically stable and ready to be discharged from the hospital
- Feeding by mouth, nasogastric tube, or gastrostomy tube
- Age 6 months or younger at discharge
- Parent or legal guardian able to give informed consent
You will not qualify if you...
- Preexisting gastrointestinal conditions that prevent formula use (e.g., necrotizing enterocolitis, short gut, malabsorption)
- Allergy or other contraindication to Fortini formula (e.g., cow's milk protein allergy)
- Currently participating in another feeding or nutrition study
- Social situations likely to prevent safe follow-up after discharge
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
Research Team
S
Sannya Hede, MD
CONTACT
E
Erin Richmond
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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