Status:
COMPLETED
Predicting Persistent Postconcussive Problems in Pediatrics (5P)
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Concussions
PCS
Eligibility:
All Genders
5-17 years
Brief Summary
Concussion, a mild traumatic injury common in children and adolescents, is a complex pathophysiological process affecting the brain. The lay press is inundated with reports of tragic consequences of c...
Detailed Description
The full protocol has been published in BMJ Open (open access): Zemek R, Osmond MH, Barrowman N for PERC Concussion Team. Predicting and preventing postconcussive problems in paediatrics (5P) study: ...
Eligibility Criteria
Inclusion
- Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they:
- are aged 5 to 17 years;
- have a concussion, defined by Zurich consensus statement;22
- suffered the initial injury in the previous 48 hours;
- are proficient in English or French.
Exclusion
- Patients will be excluded if they present with traumatic head injuries with any of the following:
- GCS ≤13; any abnormality on standard neuroimaging studies, including any positive head CT findings (Note: neuroimaging is not required, but may be performed by the clinician if thought to be clinically indicated);
- neurosurgical operative intervention, intubation or PICU care required;
- multi-system injuries with treatment requiring admission to hospital, operating room or procedural sedation in the ED (Note: admission to hospital for observation or management of ongoing concussion symptoms is not an exclusion criteria);
- severe chronic neurological developmental delay resulting in communication difficulties;
- intoxication at the time of ED presentation as per clinician judgment;
- no clear history of trauma as primary event (e.g., seizure, syncope or migraine as primary event);
- previously enrolled in this same study.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
3063 Patients enrolled
Trial Details
Trial ID
NCT01873287
Start Date
August 1 2013
End Date
June 1 2015
Last Update
November 18 2019
Active Locations (9)
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1
Stollery Children's Hospital
Edmonton, Alberta, Canada
2
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada
3
IWK Health Sciences Centre
Halifax, Nova Scotia, Canada
4
Alberta Children's Hospital
Calgary, Ontario, Canada