PCO2 ELSO (Extracorporeal Life Support Organization)

Completed

• Conditions: Respiratory Failure

• Registration Number: NCT04798794
• Lead Sponsor: Nantes University Hospital

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-12-11
• Status Verified: 2021-03
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4072

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Neurological Event	Up to 90 days after ECMO initiation	Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item: * Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI; * Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG); * Brain death clinically diagnosed

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28 days after ECMO start	Newborns died after 28 days despite ECMO assistance

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France