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

Recruiting N/A Interventional Study
Single-ventricle
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
0 Months – 6 Months
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
100 (estimated)
Sponsor
Driscoll Children's Hospital · Other
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About This Trial
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, …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Infants with single ventricle physiology who have undergone Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt) 2. Medically stable and ready for discharge from the hospital 3. Feeding via oral, nasogastric (NG), or gastrostomy tube 4. Age \< or = 6 months at tim…
Contacts

Sannya Hede, MD

361-694-5000

sannya.hede@dchstx.org

CONTACT

Erin Richmond

361-694-5978

erin.richmond@dchstx.org

CONTACT