ECMOQoL: Evaluation of Long-term Quality of Life in Children Reanimated by ExtraCorporeal Membrane Oxygenation (ECMO)

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05721105

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Extracorporeal Membrane Oxygenation Complication Critical Care	Other: Quality of life assessment using questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Evaluation of Long-term Quality of Life in Children Reanimated by ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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.
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.	Other: 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.

Arm

Intervention/Treatment

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.

Other: 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.

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Compare the overall quality of life of children aged 0-10 years supported by ECMO during their intensive care period with a population of children of the same age hospitalized in pediatric intensive care in the same period. [15 days]
Quality of life evaluated by the total score of the PedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT05721105

Other Study ID Numbers:

RC23_0013

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nantes University Hospital

Pediatric Intensive Care

Quality of life

Study Results

No Results Posted as of Feb 9, 2023