NCT04798794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,072

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

March 5, 2021

Last Update Submit

March 12, 2021

Conditions

Respiratory Failure

Keywords

EcmoNeonates

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 28-day mortality

    28 days after ECMO start

Interventions

ECMO for neonatesOTHER

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

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Support by ECMO for respiratory indication

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 15, 2021

Study Start

January 1, 2015

Primary Completion

January 1, 2020

Study Completion

December 11, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)