Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Congenital Heart Disease Clinical Trial

Official title: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Status Completed

Clinical Trial Summary

Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).

Clinical Trial Description

This study proposes a randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB). The study will focus on neonates for a few reasons. Although their post-CPB clinical course is typically more severe and intensive care unit (ICU) care more prolonged than older children, their modes of morbidity are also well characterized. Further, the high level of severity itself provides a substrate for identifying the positive effects of a particular therapy. Finally, a therapy identified as beneficial has the greatest potential for benefit in this vulnerable population. The well characterized scenario of low cardiac output syndrome (LCOS) will be used as the primary endpoint, while a variety of secondary endpoints will be related to the biochemical anti-inflammatory effects of therapy, ICU care and late neurological outcome. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Disorder of Fetus or Newborn
• Heart Defects, Congenital

• NCT number: NCT00934843
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Completion date: September 2011