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NCT Number: NCT05721105

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

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.

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Key information

Conditions

Extracorporeal Membrane Oxygenation Complication Critical Care

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life assessment using questionnaires

Other

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.

Primary outcomes

  1. 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

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.

    Time frame: up to 15 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ECMOQoL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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