Status:
COMPLETED
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Lead Sponsor:
Medical University of South Carolina
Conditions:
Congenital Heart Disease
Disorder of Fetus or Newborn
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief Summary
Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00934843
Start Date
March 1 2007
End Date
September 1 2011
Last Update
December 9 2011
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425