PCO2 ELSO (Extracorporeal Life Support Organization)

Respiratory Failure Clinical Trial

Official title:

Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798794
• Other study ID #: JS
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 11, 2020

Study information

• Verified date: March 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4072
• Est. completion date: December 11, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria :

• Support by ECMO for respiratory indication

Exclusion Criteria :

• None

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• ECMO for neonates
Neonates (<28 j) supported by ECMO for severe respiratory failure

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Neurological Event	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	Up to 90 days after ECMO initiation
Secondary	28-day mortality	Newborns died after 28 days despite ECMO assistance	28 days after ECMO start