STRESS Trial for Neonates Having Heart Surgery - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if methylprednisolone is safe and will work in children with heart disease undergoing surgery with cardiopulmonary bypass.

What is the Condition Being Studied?

Heart Surgery with Cardiopulmonary Bypass

Who Can Participate in the Study?

Infants who:
- Are less than 12 months old
- Will be undergoing planned heart surgery with cardiopulmonary bypass
- Have not taken a steroid medicine within two days of surgery

Age Group

What is Involved?

If you would like your child to be part of this study, your child will:
-- Be randomly assigned (like flipping a coin) to receive one of two different drugs:
a. High dose Methylprednisolone given at the time of surgery. or
b. Placebo, a non-active medicine, given at the time of surgery
- Be recorded about your infant's clinical course, including whether or not s/he has any complications, and how long s/he stays in the intensive care unit and in the hospital

Study Details

Full Title
STeroids to REduce Systemic inflammation after neonatal heart Surgery
Principal Investigator
Pediatric Cardiologist
Protocol Number
IRB: PRO00086082
NCT: NCT03229538
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center