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

Nantes University Hospital1 site in 1 country84 target enrollmentNovember 29, 2023

ConditionsExtracorporeal Membrane Oxygenation Complication Critical Care

Overview

Phase: N/A
Intervention: Not specified
Conditions: Extracorporeal Membrane Oxygenation Complication
Sponsor: Nantes University Hospital
Enrollment: 84
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 29, 2023

End Date

October 15, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)
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)
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)