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

CompletedOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

May 26, 2021

Primary Completion Date

July 7, 2021

Study Completion Date

July 7, 2021

Conditions
Extra Corporeal Membrane Oxygenation
Interventions
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

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."

Trial Locations (1)

75015

Hôpital Necker-Enfants Malades, Paris

All Listed Sponsors
collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER