PCO2 ELSO (Extracorporeal Life Support Organization)

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04798794
• Collaborator: (none)
• Enrollment: 4,072
• Location: 1
• Actual Duration (Months): 71.3
• Patients Per Site Per Month: 57.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Other: ECMO for neonates

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 Design

• Study Type: Observational
• Actual Enrollment: 4072 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Dec 11, 2020

Outcome Measures

Primary Outcome Measures

1. 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

1. 28-day mortality [28 days after ECMO start]

   Newborns died after 28 days despite ECMO assistance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 28 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria :

• Support by ECMO for respiratory indication

Exclusion Criteria :

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes	Loire-Atlantique	France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT04798794
• Other Study ID Numbers: JS
• First Posted: Mar 15, 2021
• Last Update Posted: Mar 15, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nantes University Hospital: Ecmo; Neonates
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Mar 15, 2021