Concussions Clinical Trial
Official title:
Predicting Persistent Postconcussive Problems in Pediatrics: A Clinical Prediction Rule Derivation and Validation Study
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 concussion, and children are not immune.
Persistent postconcussive symptoms (PCS) is defined as the persistence of somatic, cognitive,
physical, psychological or behavioural changes lasting more than one month following injury.
PCS significantly impacts children and their family's quality of life through school
absenteeism, depressed mood and loss of activities.
Validated, easy-to-use prognosticators do not exist for clinicians to identify children at
highest risk for PCS. As a result,physicians cannot accurately inform children and parents
whether they should expect longer symptoms, nor initiate pharmacotherapy or other management
to reduce the occurrence or severity of PCS.
The investigators objective is to derive and validate a clinical prediction rule for the
development of PCS in children and adolescents presenting to the emergency department (ED)
following acute head injury. The investigators have three aims: (1) determine PCS incidence
at one-month follow-up in children aged 5-17 who sustain a concussion; (2) derive a rule to
predict PCS from variables present in the history and physical examination; and, (3) assess
the accuracy, reliability and acceptability of the prediction rule in a subsequent cohort.
Using a prospective, multicentre study at nine large Canadian pediatric EDs, the
investigators will recruit the largest prospective epidemiological cohort of children with
concussions in the literature.
This work will provide rigorous evidence to determine PCS incidence in children and its
impact on quality of life. The results will enable clinicians to identify children at highest
risk for PCS, optimize treatment and provide families with realistic anticipatory guidance.
This study will also establish a strong and vital evidence base to advance concussion
research.
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: protocol for a prospective multicentre
clinical prediction rule derivation study in children with concussion. BMJ Open. 2013 Aug
1;3(8). pii:e003550. doi: 10.1136/bmjopen-2013-003550. PubMed PMID: 23906960.
https://www.ncbi.nlm.nih.gov/pubmed/23906960
The primary outcome results have been published in JAMA (open access):
Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G,
Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS,
Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson
P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond
MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for
Persistent Postconcussion Symptoms among Children With Acute Concussion in the ED. JAMA. 2016
Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203. PubMed PMID: 26954410.
http://dx.doi.org/10.1001/jama.2016.1203
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03415048 -
Longitudinal Study of Children With Concussions
|
N/A | |
| Completed |
NCT02893969 -
Pediatric Concussion Assessment of Rest and Exertion
|
N/A |