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

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication; Critical Care
• Interventions: Other: Quality of life assessment using questionnaires

• Registration Number: NCT05721105
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Study Start: 2023-11-29
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Quality of life assessment using questionnaires	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.
ECMO	Quality of life assessment using questionnaires	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.	up to 15 days

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France