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Predicting Persistent Postconcussive Problems in Pediatrics (5P) (5P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01873287
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Roger Zemek, Children's Hospital of Eastern Ontario

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.

Condition or disease
Concussions PCS

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.

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.

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Study Type : Observational
Actual Enrollment : 3063 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Persistent Postconcussive Problems in Pediatrics: A Clinical Prediction Rule Derivation and Validation Study
Study Start Date : August 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. [ Time Frame: 1 month ]
    The primary outcome is the number of of children aged 5 - 17 years who have PCS at one-month follow-up. A PCS case is defined as an increase from pre-concussion baseline of three or more symptoms on the validated PCSI at one-month (consistent with the ICD-10 definition of PCS).

Secondary Outcome Measures :
  1. Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury [ Time Frame: 1 month ]
    The PedsQL™ is a reliable and valid measure of health-related quality of life in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. The inventory covers four domains: physical, emotional, social and school. Items are calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better quality of life. This secondary outcome measure will be used to determine the impact of PCS on quality of life on patients and families.

  2. Neuropsychological Evaluation [ Time Frame: 1 month and 3 month ]
    A separate battery of neuropsychological assessment measures will be administered to those children who choose to participate in this arm of the study. This battery includes measures of intelligence, language, visual-spatial/motor functions, attention, memory/working memory, executive functioning, academic achievement, as well as behavioural/socioemotional functioning.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01873287

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Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada
Canada, Manitoba
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
IWK Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Alberta Children's Hospital
Calgary, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Roger L Zemek, MD CHEO
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Roger Zemek, Pediatric Emergentologist, Division of Emergency Medicine, Children's Hospital of Eastern Ontario Identifier: NCT01873287    
Other Study ID Numbers: CIHR-302955, CIHR-287347
First Posted: June 10, 2013    Key Record Dates
Results First Posted: November 18, 2019
Last Update Posted: November 18, 2019
Last Verified: October 2019
Keywords provided by Roger Zemek, Children's Hospital of Eastern Ontario:
Persistent post-concussion symptoms
Clinical Prediction Rule