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

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.

Study Overview

• Status: Completed
• Conditions: Extra Corporeal Membrane Oxygenation
• Intervention / Treatment: 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)

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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; Other: Pediatric 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.; Other Names: Quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of neurological lesions	Description of different types of neurological complications acquired under ECMO with brain CT scan or MRI.	9 days
Death	Number of death.	6 years
Delay between ECMO withdrawal and death	Children who died after ECMO withdrawal.	6 years
Neurological assessment	Score at DENVER scale or Pediatric Cerebral Performance Category (PCPC) score.	At one year after ECMO withdrawal, and in 2020
Quality of life assessment	Score at Pediatric Quality of Life Inventory™ (PedsQL).	At one year after ECMO withdrawal, and in 2020

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Judith Chareyre, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Neurological outcome; Pediatric patients; Neurological complications; Extra corporeal membrane oxygenation
• Other Study ID Numbers: APHP200675; 2020-A01185-34 (Other Identifier: IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No