Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO)

NCT ID: NCT05721105

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-29

Study Completion Date

2024-10-15

Brief Summary

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The main objective of this prospective transversal comparative study is to describe the quality of life of children supported by ECMO. These patients are described in detail at the Nantes University Hospital, in particular the elements of neurological monitoring. These results will be analyzed in reference to a population hospitalized at the same age, in the same period, and sharing the same diagnostic categories.

Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation Complication Critical Care

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ECMO

50 Patients admitted to pediatric intensive care at the University Hospital of Nantes between January 2014 and December 2022 and supported by ECMO during their hospitalization.

Quality of life assessment using questionnaires

Intervention Type OTHER

Several quality of life questionnaires will be submitted to the patients and their parents. The questionnaires will be adapted to the age of the patients.

Control

50 patients hospitalized at the same age, during the same time period, and sharing the same diagnostic categories as the ECMO group, but the control group never had ECMO.

Quality of life assessment using questionnaires

Intervention Type OTHER

Several quality of life questionnaires will be submitted to the patients and their parents. The questionnaires will be adapted to the age of the patients.

Interventions

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Quality of life assessment using questionnaires

Several quality of life questionnaires will be submitted to the patients and their parents. The questionnaires will be adapted to the age of the patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients accepted in pediatric intensive care at the Nantes University Hospital between January 2014 and December 2022
* Patients less than 10 years old at admission to the intensive care unit,
* Patients older than 2 years at the time of the cross-sectional evaluation
* For the ECMO group: Patients supported by ECMO
* For the control group: Patient intubated-ventilated for more than 48 hours and/or having received amines and/or having received organ support other than ECMO.
* Patient affiliated to the Social Security.
* Patient with parents who do not object to the study

Exclusion Criteria

* Known genetic pathology or malformative association at the time of admission to the intensive care unit that could lead to severe neurodevelopmental deficits, independently of the medical events that resulted in the admission to the intensive care unit
* Language difficulty that does not allow for complete information and questionnaire collection
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

Other Identifiers

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RC23_0013

Identifier Type: -

Identifier Source: org_study_id

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