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

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Critical Care
Extracorporeal Membrane Oxygenation Complication

Treatments

Other: Quality of life assessment using questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT05721105
RC23_0013

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

ECMO
Description:
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.
Treatment:
Other: Quality of life assessment using questionnaires
Control
Description:
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.
Treatment:
Other: Quality of life assessment using questionnaires

Trial contacts and locations

1

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Central trial contact

Pierre BOURGOIN, PH

Data sourced from clinicaltrials.gov

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