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

Extra Corporeal Membrane Oxygenation Clinical Trial

— NeurECMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519528
• Other study ID #: APHP200675
• Secondary ID: 2020-A01185-34
• Status: Completed
• Start date: May 26, 2021
• Est. completion date: July 7, 2021

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Extra Corporeal Membrane Oxygenation

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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 Memb — View Citation

Outcome

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