Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04798794
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCO2 ELSO (Extracorporeal Life Support Organization)
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.
Detailed Description:
Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: