Concussions5PNCT01873287

Predicting Persistent Postconcussive Problems in Pediatrics (5P)

An observational study of Concussions and PCS, run by Children's Hospital of Eastern Ontario at 9 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Concussions, PCS
How many people: 3,063 participants
Where: 9 sitesCanada
Study dates: Aug 2013to Jun 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
All sexes
No healthy volunteers
Child

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.

Who may be able to join

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:

Show all 13Show fewer

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.

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Canada9 sites

Alberta Children's Hospital
Calgary, Ontario
Stollery Children's Hospital
Edmonton, Alberta
IWK Health Sciences Centre
Halifax, Nova Scotia
Children's Hospital of Western Ontario
London, Ontario
CHU Sainte-Justine
Montreal, Quebec
Montreal Children's Hospital
Montreal, Quebec
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario
Children's Hospital of Winnipeg
Winnipeg, Manitoba

Other trials in Canada

About this study

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

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.

Read the 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

Conditions: Concussions, PCS
Keywords: Concussions, Persistent post-concussion symptoms, PCS, Clinical Prediction Rule

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 1 month

Secondary outcomes (2)

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.
Measured: 1 month
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.
Measured: 1 month and 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jun 2015

First posted10 Jun 2013 (estimated)
Study startAug 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ConcussionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,063 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01873287
Sponsor's protocol ID: CIHR-302955, CIHR-287347
Acronym: 5P
Status last verified: Oct 2019
First submitted: 6 Jun 2013
Last updated: 18 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 36854112
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.
PubMed 32499388
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.
PubMed 31316452
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.
PubMed 23906960

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
COmmunities Aligned to Reduce Concussion and Head Impact Exposure
Concussions
RecruitingObservational study
The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
REM Sleep Behavior Disorder, Concussion, Brain
Active, not recruitingObservational study
ATI Evidence-based Guide Investigating Medical and Preventative Services
Sport Medicine
Not yet recruiting
Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Concussions, Mild Traumatic Brain Injury, Concussion
Not yet recruiting
Female Concussion Head Cooling
Concussion (Diagnosis), Concussion Post Syndrome

All Concussions trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Persistent Postconcussive Problems in Pediatrics: A Clinical Prediction Rule Derivation and Validation Study
ClinicalTrials.gov ID: NCT01873287
Acronym / sponsor ID: 5P / CIHR-302955, CIHR-287347
Conditions: Concussions, PCS
Keywords: Concussions, Persistent post-concussion symptoms, PCS, Clinical Prediction Rule
Study type: Observational
Recruitment status: Completed
Enrolment: 3,063 participants (actual)
Lead sponsor: Children's Hospital of Eastern OntarioUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR)
Study start: Aug 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 10 Jun 2013 (estimated)
Results: Posted 18 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The full protocol has been published in BMJ Open (open access):

The primary outcome results have been published in JAMA (open access):

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 5 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
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.

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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).

2 secondary outcomes

Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury
Time frame: 1 month
Neuropsychological Evaluation
Time frame: 1 month and 3 month

Results and safety

Results posted to the registry on 18 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Derivation Arm	2,006	1,701
Validation Arm	1,057	883

Primary outcome: Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up.

Time frame: 1 month. Count of participants. Unit: Participants

Measure	PPCS in Derivation n = 1701	PPCS in Validation n = 883
Value	510	291

Population analysed: Completed 1-month followup.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants	0 of 3,063 (0%)	0 of 3,063 (0%)	0 of 3,063

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36854112Engel 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.
Derived from this study: PubMed 32499388Gagnon 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.
Derived from this study: PubMed 31316452Teel 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.
Derived from this study: PubMed 23906960Zemek 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.

Related trials for Concussions

Recruiting
COmmunities Aligned to Reduce Concussion and Head Impact Exposure
Concussions
RecruitingObservational study
The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
REM Sleep Behavior Disorder, Concussion, Brain
Active, not recruitingObservational study
ATI Evidence-based Guide Investigating Medical and Preventative Services
Sport Medicine
Not yet recruiting
Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Concussions, Mild Traumatic Brain Injury, Concussion
Not yet recruiting
Female Concussion Head Cooling
Concussion (Diagnosis), Concussion Post Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roger L Zemek, MD principal investigator

CHEO

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Concussions and PCS, run by Children's Hospital of Eastern Ontario at 9 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01873287, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.