Predicting Persistent Postconcussive Problems in Pediatrics (5P)

Concussions Clinical Trial

— 5P  

Official title:

Predicting Persistent Postconcussive Problems in Pediatrics: A Clinical Prediction Rule Derivation and Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873287
• Other study ID #: CIHR-302955, CIHR-287347
• Status: Completed
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2019
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3063
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Concussions
• PCS

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Ontario
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Sciences Centre	Halifax	Nova Scotia
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Children's Hospital of Winnipeg	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up.	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).	1 month
Secondary	Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury	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.	1 month
Secondary	Neuropsychological Evaluation	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.	1 month and 3 month