Clinical trial NCT05721105: Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO)
Official title: Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation Complication
Critical Care
Keywords: Pediatric Intensive Care
Quality of life
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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.


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

Primary outcomes:
measure: 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.
timeFrame: 15 days
Secondary outcomes:
measure: 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
timeFrame: up to 15 days
measure: 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
timeFrame: up to 15 days
measure: Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: