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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04519528
Acronym
NeurECMO
Enrollment
40
Registered
2020-08-19
Start date
2021-05-26
Completion date
2021-07-07
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra Corporeal Membrane Oxygenation

Keywords

Extra corporeal membrane oxygenation, Pediatric patients, Neurological complications, Neurological outcome, Quality of life

Brief summary

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.

Detailed description

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.

Interventions

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

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).

OTHERPediatric Quality of Life Inventory™ (PedsQL)

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Risk factors of neurological complications9 daysIdentification of risk factors of neurological complications acquired under ECMO by significant association between neurological lesions diagnosed on imaging and the co-variables.

Secondary

MeasureTime frameDescription
Diagnosis of neurological lesions9 daysDescription of different types of neurological complications acquired under ECMO with brain CT scan or MRI.
Death6 yearsNumber of death.
Delay between ECMO withdrawal and death6 yearsChildren who died after ECMO withdrawal.
Neurological assessmentAt one year after ECMO withdrawal, and in 2020Score at DENVER scale or Pediatric Cerebral Performance Category (PCPC) score.
Quality of life assessmentAt one year after ECMO withdrawal, and in 2020Score at Pediatric Quality of Life Inventory™ (PedsQL).

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJudith Chareyre, MD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026