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Completed

NCT Number: NCT04798794

PCO2 ELSO (Extracorporeal Life Support Organization)

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Support by ECMO for respiratory indication

Exclusion criteria

  • None

Treatment and study plan

ECMO for neonates

Other

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

Primary outcomes

  1. Acute Neurological Event

    Time frame: 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 outcomes

  1. 28-day mortality

    Time frame: 28 days after ECMO start

    Newborns died after 28 days despite ECMO assistance

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2021
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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