Status:
UNKNOWN
Feasibility Study for Neurodevelopment Follow-up Study in PICU
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
St. Justine's Hospital
Conditions:
Bronchiolitis Acute
Pneumonia
Eligibility:
All Genders
Up to 52 years
Brief Summary
There is a large and growing body of animal evidence demonstrating neuroapoptosis and neurodevelopmental abnormalities after exposure to anesthetic agents. This has prompted an FDA warning concerning ...
Detailed Description
The majority of human cohort investigations of neurotoxicity have studied general anesthesia for surgery. However, many animal studies have involved exposure to agents for significantly longer than th...
Eligibility Criteria
Inclusion
- infants treated for bronchiolitis or pneumonia requiring respiratory support either intubation and IPPV needing sedation OR requiring non-invasive ventilation without sedation
Exclusion
- prematurity less than 28 weeks, congenital heart disease, genetic or chromosomal anomalies, neurological disease, exposure to anesthesia in utero or prior to PICU admission, GA longer than 60 minutes or repeated PICU sedation since original admission.
- logistical exclusions: language other than English or French for which testing tools are available; geographical distance precluding return for testing appointment.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03345628
Start Date
February 1 2018
End Date
December 30 2021
Last Update
February 21 2020
Active Locations (1)
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1
McGill University Health Center
Montreal, Quebec, Canada, H3Y 3A2