Clinical trial NCT01873287: Predicting Persistent Postconcussive Problems in Pediatrics (5P)
Official title: Predicting Persistent Postconcussive Problems in Pediatrics: A Clinical Prediction Rule Derivation and Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussions
PCS
Keywords: Concussions
Persistent post-concussion symptoms
PCS
Clinical Prediction Rule
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-06-10
Enrollment: 3063
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting to one the nine participating Canadian pediatric hospitals (IWK Health Sciences Centre (NS), CHU Sainte-Justine (PQ), Montreal Children's Hospital (PQ), Children's Hospital of Eastern Ontario (ON), The Hospital for Sick Children (ON), Children's Hospital of Western Ontario (ON), Children's Hospital of Winnipeg (MB), Stollery Children's Hospital (AB) and Alberta Children's Hospital (AB)) EDs after sustaining a head injury.

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 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.

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: 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

Eligibility criteria: Inclusion Criteria:

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 Criteria: 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.

Primary outcomes:
measure: Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up.
timeFrame: 1 month
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury
timeFrame: 1 month
measure: Neuropsychological Evaluation
timeFrame: 1 month and 3 month
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Children's Hospital of Winnipeg
state: Manitoba
city: Halifax
country: Canada
facility: IWK Health Sciences Centre
state: Nova Scotia
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: CHEO
name: Roger L Zemek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gagnon I, Teel E, Gioia G, Aglipay M, Barrowman N, Sady M, Vaughan C, Zemek R; PEDIATRIC EMERGENCY RESEARCH CANADA (PERC) 5P TEAM. Parent-Child Agreement on Postconcussion Symptoms in the Acute Postinjury Period. Pediatrics. 2020 Jul;146(1):e20192317. doi: 10.1542/peds.2019-2317. Epub 2020 Jun 4.
citation: Teel EF, Zemek RL, Tang K, Gioia G, Vaughan C, Sady M, Gagnon IJ; Pediatric Emergency Research Canada (PERC) Concussion Team. The Stability of Retrospective Pre-injury Symptom Ratings Following Pediatric Concussion. Front Neurol. 2019 Jun 27;10:672. doi: 10.3389/fneur.2019.00672. eCollection 2019.
citation: Zemek R, Osmond MH, Barrowman N; Pediatric Emergency Research Canada (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):e003550. doi: 10.1136/bmjopen-2013-003550.