Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Completed · Not applicable

Conditions studied: Congenital Heart Disease, Disorder of Fetus or Newborn

In brief

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

Key facts

Study ID

NCT00934843

Run by

Medical University of South Carolina

People needed

77

Starts

2007-03-01

Expected to finish

2011-09-01

Last updated by the study team

2011-12-09

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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