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Completed

NCT Number: NCT04519528

Acute Neurological Complications and Neurodevelopmental Outcome in Children Undergoing Extracorporeal Membrane Oxygenation.

The purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent extracorporeal membrane oxygenation (ECMO), and their risk factors. The research will also assess the child health at 1 year after withdrawal from ECMO and in 2020 in terms of neurological state and quality of life.

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Key information

Conditions

Extra Corporeal Membrane Oxygenation

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

Neurological complications are relatively common (around 30%) in patients undergoing extra corporeal membrane oxygenation (ECMO). They can be hemorrhagic or ischemic and are partly due to the difficulty of balancing heparin therapy. Few pediatric studies have estimated the incidence and risk factors for these lesions. In addition, the developmental monitoring and quality of life of these children is not systematic or standardized, and their long-term outcome deserves to be better evaluated.

The purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent veno-veinous or veno-arterial ECMO and their risk factors. The study is being conducted at Necker Enfants Malades hospital between 2014 and 2019. The research will also assess the child health at 1 year after withdrawal from ECMO and in 2020 in terms of neurological state and quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children from 0 to 18 years hospitalized in PICU (pediatric intensive care unit) and who underwent veno-venous or veno-arterial extra corporeal membrane oxygenation (ECMO) between 2014 and 2019.
  • Adult patients not oppose to participation in research or holders of parental authority of minor patients not opposed to participation in the study.

Exclusion criteria

  • Other type of assistance than an ECMO (Berlin heart).

Treatment and study plan

DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old)

Other

The DENVER II is a measure of developmental problems in young children. It was designed to assess child performance on various age-appropriate tasks and compares a given child's performance to the performance of other children the same age. The instrument consists of 125 tasks, which broadly reflect the following areas: personal-social, fine motor-adaptive, language, and gross motor.

The target population corresponds to infants and pre-school age children.

The POPC and PCPC are global scales based on observer impressions. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma (6 indicates death).

Other names: Neurological assessment

Pediatric Quality of Life Inventory™ (PedsQL)

Other

The PedsQL questionnaire is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. Twenty-three items divided into different functional areas are evaluated: physical (8 items), emotional (5 items), social (5 items) and school (5 items over 4 years old; 3 items before 4 y.o).

Child self-report and parent proxy report formats of the questionnaire allows self-assessment of child over 5 years old and parents' evaluations. Items can be reverse and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) with higher scores indicating better quality of life.

Other names: Quality of life assessment

Primary outcomes

  1. Risk factors of neurological complications

    Time frame: 9 days

    Identification of risk factors of neurological complications acquired under ECMO by significant association between neurological lesions diagnosed on imaging and the co-variables.

Secondary outcomes

  1. Diagnosis of neurological lesions

    Time frame: 9 days

    Description of different types of neurological complications acquired under ECMO with brain CT scan or MRI.

  2. Death

    Time frame: 6 years

    Number of death.

  3. Delay between ECMO withdrawal and death

    Time frame: 6 years

    Children who died after ECMO withdrawal.

  4. Neurological assessment

    Time frame: At one year after ECMO withdrawal, and in 2020

    Score at DENVER scale or Pediatric Cerebral Performance Category (PCPC) score.

  5. Quality of life assessment

    Time frame: At one year after ECMO withdrawal, and in 2020

    Score at Pediatric Quality of Life Inventory™ (PedsQL).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: NeurECMO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2020
Registry last updated
Mar 9, 2026

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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