Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

NACompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

May 25, 2018

Study Completion Date

December 19, 2018

Conditions
Congenital Heart DiseaseDisorder of Fetus or Newborn
Interventions
DRUG

Methylprednisolone

Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

DRUG

Placebo

Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Trial Locations (2)

29425

Medical University of South Carolina, Pediatric Cardiology, Charleston

30233

Children's Healthcare of Atlanta/Emory University, Atlanta

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Medical University of South Carolina

OTHER

NCT01579513 - Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass | Biotech Hunter | Biotech Hunter