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New treatment option for Single-ventricle
Official title Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
ClinicalTrials.gov ID: NCT07087782
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 6
You may be able to join 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 likely can't join 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 treatment feeding or nutrition study
- Social circumstances likely to preclude safe outpatient follow up
The study team makes the final eligibility decision.
Where it's taking place
- Corpus Christi, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 6 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Corpus Christi, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.