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

Study Overview
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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.

Official Title
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Evaluation of Long-term Quality of Life in Children Supported With ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study

Conditions
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Extracorporeal Membrane Oxygenation Complication, Critical Care

Intervention / Treatment
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* Other: Quality of life assessment using questionnaires


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECMO<br>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<br>* 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.<br>|
| Control<br>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<br>* 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.<br>|

What is the study measuring?
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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. | 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 | 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 | 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 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Intensive Care, Quality of life