Predicting Persistent Postconcussive Problems in Pediatrics (5P)

NCT01873287 | Completed Results

• 1 other identifier: CIHR-302955, CIHR-287347
• Study Type: observational
• Target: 3,063
• Locations: 1 country
• Sites: 9

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.

Conditions

Concussions; PCS

Keywords

Concussions; Persistent post-concussion symptoms; PCS; Clinical Prediction Rule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury

  1 month

• Neuropsychological Evaluation

  1 month and 3 month

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (9)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

Location

IWK Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Alberta Children's Hospital

Calgary, Ontario, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, Canada

Location

Related Publications (4)

• Engel J, van Ierssel JJ, Osmond MH, Tsampalieros A, Webster R, Zemek R. Return to the Emergency Department Within 3 Months Following Pediatric Acute Concussion. J Head Trauma Rehabil. 2023 Jul-Aug 01;38(4):319-328. doi: 10.1097/HTR.0000000000000852. Epub 2023 Feb 28.

  PMID: 36854112 DERIVED

• 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.

  PMID: 32499388 DERIVED

• 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.

  PMID: 31316452 DERIVED

• 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.

  PMID: 23906960 DERIVED

Limitations and Caveats

Selection bias (children presenting to ED as compared to general primary care) may limit generalizability. There is no control group (e.g., orthopedic injury) to compare symptom scores. Socio-economic status and race data were not collected.

Results Point of Contact

• Title: Dr. Roger Zemek
• Organization: Children's Hospital of Eastern Ontario

rzemek@cheo.on.ca

613-737-7600

Study Officials

• Roger L Zemek, MD

  CHEO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergentologist, Division of Emergency Medicine

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

CA (9)