Clinical trial NCT04519528: Acute Neurological Complications and Neurodevelopmental Outcome in Children Undergoing Extracorporeal Membrane Oxygenation.
Official title: Acute Neurological Complications and Neurodevelopmental Outcome in Children Undergoing Extracorporeal Membrane Oxygenation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extra Corporeal Membrane Oxygenation
Keywords: Extra corporeal membrane oxygenation
Pediatric patients
Neurological complications
Neurological outcome
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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 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).

Primary outcomes:
measure: Risk factors of neurological complications
timeFrame: 9 days
Secondary outcomes:
measure: Diagnosis of neurological lesions
timeFrame: 9 days
measure: Death
timeFrame: 6 years
measure: Delay between ECMO withdrawal and death
timeFrame: 6 years
measure: Neurological assessment
timeFrame: At one year after ECMO withdrawal, and in 2020
measure: Quality of life assessment
timeFrame: At one year after ECMO withdrawal, and in 2020
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Judith Chareyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.