Ventilator Settings and Outcomes in Pediatric Patients on... | NCT06899009

Studies
Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure

NCT06899009

Sponsor

University Medical Center Groningen

Status

Active, not recruiting

Last Update Posted

Mar 27, 2025Actual

Enrollment

750Actual

Phase

Not provided

Conditions

Critical Illness
Respiratory Failure (Pediatric Patients)

Interventions

Not provided

Countries

Netherlands

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 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Mar 1, 2025Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 20, 2025

First Submission Date that Met QC Criteria

Mar 20, 2025

First Posted Date

Mar 27, 2025Actual

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 20, 2025

Last Update Posted Date

Mar 27, 2025Actual

Name	Class
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	OTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation and to explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure, using the 'Extracorporeal Life Support Organization' (ELSO) registry.

Detailed Description

Rationale:

Despite the growing use of ECMO in critically ill pediatric patients, uncertainties remain to what extent adjustments of ventilator settings after ECMO initiation are associated with mortality.

Objectives:

To describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation; and
To explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure

Hypothesis:

Ventilation intensity decreases following initiation of ECMO; and
A decrease in ventilation intensity is associated with lower hospital mortality in critically ill pediatric patients.

Study design:

This is a posthoc analysis of the ELSO registry.

Study population:

For this analysis, data will be obtained from the ELSO registry. All pediatric patients (aged ≥29 days to ≤18 years) receiving ECMO for a pulmonary indication between January 1, 2012, and December 31, 2022 will be included. Patients with missing ventilatory variables required to assess ventilation intensity and patients lost to follow up with respect to hospital mortality will be excluded.

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

750Actual

Label	Type	Description	Intervention Names
Children with respiratory failure on ECMO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital mortality		Up to 90 days of study or whatever comes first

Secondary Outcomes

Measure	Description	Time Frame
Hospital length of stay		Up to 90 days of study or whatever comes first
Duration of ECMO run		Up to 90 days of study or whatever comes first
Duration of invasive ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (aged ≥29 days to ≤18 years) receiving ECMO between January 1, 2012, and December 31, 2022, in an ELSO affiliated center; and
Requiring ECMO for a pulmonary indication.

Exclusion Criteria:

Patients with missing ventilatory variables required to assess ventilation intensity;
patients who were lost to follow up with respect to hospital mortality.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

29 Days

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Critically ill pediatric patients receiving ECMO for pulmonary indications

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin CJ Kneyber, MD PhD FCCM	University Medical Center Groningen	Principal Investigator
Marcus J Schultz, MD PhD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator
Frederique Paulus, RN PhD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen			Netherlands

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
D016638	Critical Illness
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders

Browse Leaves

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Browse Branches

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