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PCO2 ELSO (Extracorporeal Life Support Organization)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04798794
Enrollment
4072
Registered
2021-03-15
Start date
2015-01-01
Completion date
2020-12-11
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

Ecmo, Neonates

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.

Interventions

OTHERECMO for neonates

Neonates (\<28 j) supported by ECMO for severe respiratory failure

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

: * Support by ECMO for respiratory indication

Exclusion criteria

: * None

Design outcomes

Primary

MeasureTime frameDescription
Acute Neurological EventUp to 90 days after ECMO initiationOnset 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

MeasureTime frameDescription
28-day mortality28 days after ECMO startNewborns died after 28 days despite ECMO assistance

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026