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

Critical Care Clinical Trial

— ECMOQoL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721105
• Other study ID #: RC23_0013
• Status: Recruiting
• Start date: November 29, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: Pierre BOURGOIN, PH
• Phone: +33683490905
• Email: pierre.bourgoin[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Extracorporeal Membrane Oxygenation Complication

Intervention

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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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