Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO) (ECMOQoL)
November 18, 2024 updated by: Nantes University Hospital
Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Loire-Atlantique
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Nantes, Loire-Atlantique, France, 44093
- Nantes University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The patients included (ECMO group) will be patients under 10 years of age treated by ECMO at the University Hospital of Nantes from January 2014 to December 2022 and who have reached the age of 2 years during the study (the hetero-evaluation questionnaires for the primary endpoint being validated from this age).
The controls will be patients hospitalized at the same age in pediatric intensive care and at the same periods, who have been intubated and ventilated for at least 48 hours, and/or who have received amines and/or who have benefited from organ support other than ECMO (CONTROL group).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 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.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care with reference to a population of children of the same age hospitalized in pediatric intensive care during the same period
Time Frame: up to 15 days
|
PedsQL (Pediatric Quality of Life Questionnaire) : Physical functioning, emotional functioning, social functioning, academic functioning. PedsQL (Pediatric Quality of Life Questionnaire), scale from 0 to 4; 4 being the worst outcome. |
up to 15 days
|
|
To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care stay to a reference consisting of healthy children, not hospitalized, studied over the same period and in the same country
Time Frame: up to 15 days
|
PedsQL Questionnaire scores of a cohort of healthy children of the same age from the literature. PedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome. |
up to 15 days
|
|
Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.
Time Frame: up to 15 days
|
up to 15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2023
Primary Completion (Actual)
October 15, 2024
Study Completion (Actual)
October 15, 2024
Study Registration Dates
First Submitted
January 31, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (Actual)
February 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 20, 2024
Last Update Submitted That Met QC Criteria
November 18, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC23_0013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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