Acute Neurological Complications and Neurodevelopmental Outcome in Children Undergoing Extracorporeal Membrane Oxygenation.
Overview
- Phase
- Not Applicable
- Intervention
- DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old)
- Conditions
- Extra Corporeal Membrane Oxygenation
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Risk factors of neurological complications
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
- •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).
Arms & Interventions
Patients
Minors who required veno-venous or veno-arterial ECMO, in pediatric intensive care unit at Necker Enfants Malades hospital between 2014 and 2019.
Intervention: DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old)
Patients
Minors who required veno-venous or veno-arterial ECMO, in pediatric intensive care unit at Necker Enfants Malades hospital between 2014 and 2019.
Intervention: Pediatric Quality of Life Inventory™ (PedsQL)
Outcomes
Primary Outcomes
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
- Diagnosis of neurological lesions(9 days)
- Delay between ECMO withdrawal and death(6 years)
- Quality of life assessment(At one year after ECMO withdrawal, and in 2020)
- Neurological assessment(At one year after ECMO withdrawal, and in 2020)
- Death(6 years)