Actively Recruiting
Impact of Early Fortini Formula Use on Growth and Outcomes in Infants With Single Ventricle Heart Condition
Led by Driscoll Children's Hospital · Updated on 2026-05-13
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates whether Fortini, a high-calorie, low osmolality formula, can help infants with single ventricle physiology grow better after their first heart surgery (Stage 1 surgical palliation). These infants often have trouble gaining weight, which can lead to more health problems before their next surgery. The study aims to improve nutrition care and reduce caregiver stress for these high-risk babies during the critical interstage period. Babies will be randomly assigned to one of two groups after their initial heart surgery but before hospital discharge. One group will receive Fortini formula, which provides 30 kcal/oz with lower volume, while the other group will receive standard high-calorie fortified infant formulas (24-30 kcal/oz). The infants will be followed until their next surgery, about 4 months later, to compare growth and feeding outcomes between the two groups. Participants will be monitored through weight measurements, feeding tolerance checks, daily calorie intake tracking, hospital readmission records, and caregiver feedback about feeding stress. The main measure is the change in weight-for-age Z-score by 4 to 6 months. Safety and caregiver experience will also be assessed. The total study duration for each infant is up to 4 months, with about 100 infants expected to join at Driscoll Children's Hospital.
CONDITIONS
Brief 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 heart surgery (e.g., Norwood, hybrid, or BT shunt)
- Medically stable and ready for hospital discharge
- Feeding by mouth, nasogastric (NG), or gastrostomy tube
- Age less than or equal to 6 months at discharge
- Parent or legal guardian able to give informed consent
You will not qualify if you...
- Gastrointestinal conditions that prevent formula use (e.g., necrotizing enterocolitis, short gut, malabsorption)
- Known allergy or contraindication to Fortini formula (e.g., cow's milk protein allergy)
- Currently enrolled in another feeding or nutrition intervention study
- Social situations that make safe outpatient follow-up unlikely
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 months
Participants receive either Fortini formula or standard nutritional care after hospital discharge to support growth and feeding in infants with single ventricle physiology.
Regular visits during the treatment period as per study protocol
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
E
Erin Richmond
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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