Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

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Trial ID: NCT02320669

Age - N/A-5 Months Condition - Pediatric Cardiology, Pediatric Medical Genetics Gender - All Accepting Healthy Volunteers - No

Purpose

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.

Official Title

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Stanford Investigator(s)

Richard D. Mainwaring

Eligibility


Inclusion Criteria:

   1. Informed consent obtained

   2. Male and female patients <5 months (152 days) of age

   3. Patients undergoing cardiopulmonary bypass

Exclusion Criteria:

   1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has
   thyroid disease)

   2. Trisomy 13 and 18

   3. Prolonged preoperative ventilator support which would not be impacted by cardiac
   surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with
   diaphragmatic hernia)

   4. Any other condition as determined by the PI causing prolonged ventilator support which
   is unlikely to respond favorably to cardiac surgery

   5. Prior participation in the clinical trial

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Intervention(s):

drug: Triostat

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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