Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

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

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.

Inclusion Criteria:

• Neonates Age </= 1 month
• 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: </= 36 weeks post gestational age at time of surgery
• 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