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

NCT04519528 | Completed

• 2 other identifiers: APHP2006752020-A01185-34
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Extra Corporeal Membrane Oxygenation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Risk factors of neurological complications

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

  9 days

Secondary Outcomes (5)

• Diagnosis of neurological lesions

  9 days

• Death

  6 years

• Delay between ECMO withdrawal and death

  6 years

• Neurological assessment

  At one year after ECMO withdrawal, and in 2020

• Quality of life assessment

  At one year after ECMO withdrawal, and in 2020

Study Arms (1)

Patients

Minors who required veno-venous or veno-arterial ECMO, in pediatric intensive care unit at Necker Enfants Malades hospital between 2014 and 2019.

Other: DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old); Other: Pediatric Quality of Life Inventory™ (PedsQL)

Interventions

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).

Also known as: Neurological assessment

Patients

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.

Also known as: Quality of life assessment

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Minors from 0 to 18 years hospitalized in pediatric resuscitation of Necker hospital and placed on veno-venous or veno-arterial extra corporeal membrane oxygenation (ECMO) between 2014 and 2019.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• Michel A, Vedrenne-Cloquet M, Kossorotoff M, Thy M, Levy R, Pouletty M, De Marcellus C, Grimaud M, Moulin F, Hully M, Simonnet H, Desguerre I, Renolleau S, Oualha M, Chareyre J. Neurologic Outcomes and Quality of Life in Children After Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2024 Mar 1;25(3):e158-e167. doi: 10.1097/PCC.0000000000003419. Epub 2023 Dec 13.

  PMID: 38088764 RESULT

Study Officials

• Judith Chareyre, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: May 26, 2021
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)