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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Extra Corporeal Membrane Oxygenation

Being tested

DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old), Pediatric Quality of Life Inventory™ (PedsQL)

Keywords

Extra corporeal membrane oxygenation, Pediatric patients, Neurological complications, Neurological outcome, Quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old)Other

  Also called Neurological assessment

  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)Other

  Also called Quality of life assessment

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 9 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Aug 2020
2. Study start26 May 2021
3. Primary completion7 Jul 2021
4. Study completion7 Jul 2021

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Extra Corporeal Membrane OxygenationStudies of the same condition, open and under way.
• More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.