PCO2 ELSO (Extracorporeal Life Support Organization) | NCT04798794

Studies
PCO2 ELSO (Extracorporeal Life Support Organization)

NCT04798794

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Mar 15, 2021Actual

Enrollment

4,072Actual

Phase

Not provided

Conditions

Respiratory Failure

Interventions

ECMO for neonates

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Dec 11, 2020Actual

First Submitted Date

Mar 5, 2021

First Submission Date that Met QC Criteria

Mar 12, 2021

First Posted Date

Mar 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2021

Last Update Posted Date

Mar 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,072Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECMO for neonates	Other	Neonates (<28 j) supported by ECMO for severe respiratory failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
28-day mortality	Newborns died after 28 days despite ECMO assistance	28 days after ECMO start

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Support by ECMO for respiratory indication

Exclusion Criteria :

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes	Loire-Atlantique	44093	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015199	Extracorporeal Membrane Oxygenation

Ancestor Terms

ID	Term
D012138	Respiratory Therapy
D013812	Therapeutics
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided