Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00934843
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2009-07-06
Brief Title:
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None