Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

NACompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Congenital Heart DiseaseDisorder of Fetus or Newborn
Interventions
DRUG

methylprednisolone (IVMP)

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive ONE doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP (2 dose steroid)to intraoperative IVMP alone (single dose steroid) on the inflammatory response to CPB cardiopulmonary bypass.

DRUG

methylprednisolone (two doses IVMP)

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive TWO doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP to intraoperative IVMP alone on the inflammatory response to CPB cardiopulmonary bypass. The hypothesis is that neonates treated with preoperative IVMP as well as the standard intraoperative IVMP will have decreased production of pro-inflammatory cytokines.

Trial Locations (1)

29425

Medical University of South Carolina, Charleston

All Listed Sponsors
lead

Medical University of South Carolina

OTHER

NCT00934843 - Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass | Biotech Hunter | Biotech Hunter