Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Glucocorticoids; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Neonates Age
• Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)

• Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion Criteria:

• Prematurity:
• Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery

• Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization

• Suspected infection that would contraindicate steroid use (eg - Herpes)

• Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding)

• Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization

• Inability to begin the pre-operative study drug at least 8 hours prior to surgery