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

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ClinicalTrials.gov Identifier: NCT01873287
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : January 28, 2016
Sponsor:
Collaborator:
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

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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. Proportion of children who have PCS at one-month follow-up. [ Time Frame: 1 month ]
    The primary outcome is the proportion 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 [ 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. 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

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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.
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01873287


Locations
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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)
Investigators
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Principal Investigator: Roger L Zemek, MD CHEO

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roger Zemek, Pediatric Emergentologist, Division of Emergency Medicine, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01873287     History of Changes
Other Study ID Numbers: CIHR-302955, CIHR-287347
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Roger Zemek, Children's Hospital of Eastern Ontario:
Concussions
Persistent post-concussion symptoms
PCS
Clinical Prediction Rule