Acute Neurological Complications and Neurodevelopmental Outcome in Children Undergoing Extracorporeal Membrane Oxygenation.
- Conditions
- Extra Corporeal Membrane Oxygenation
- Interventions
- 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)
- Registration Number
- NCT04519528
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- Other type of assistance than an ECMO (Berlin heart).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Pediatric Quality of Life Inventory™ (PedsQL) Minors who required veno-venous or veno-arterial ECMO, in pediatric intensive care unit at Necker Enfants Malades hospital between 2014 and 2019. Patients DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old) Minors who required veno-venous or veno-arterial ECMO, in pediatric intensive care unit at Necker Enfants Malades hospital between 2014 and 2019.
- Primary Outcome Measures
Name Time Method Risk factors of neurological complications 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 Outcome Measures
Name Time Method Diagnosis of neurological lesions 9 days Description of different types of neurological complications acquired under ECMO with brain CT scan or MRI.
Delay between ECMO withdrawal and death 6 years Children who died after ECMO withdrawal.
Quality of life assessment At one year after ECMO withdrawal, and in 2020 Score at Pediatric Quality of Life Inventory™ (PedsQL).
Neurological assessment At one year after ECMO withdrawal, and in 2020 Score at DENVER scale or Pediatric Cerebral Performance Category (PCPC) score.
Death 6 years Number of death.
Trial Locations
- Locations (1)
Hôpital Necker-Enfants Malades
🇫🇷Paris, France