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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
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Roger Zemek, Children's Hospital of Eastern Ontario

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Concussions
PCS
Enrollment 3063
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Derivation Arm Validation Arm
Hide Arm/Group Description

Inclusion criteria. Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they: (1) are aged 5 to 17 years; (2) have a concussion, defined by Zurich consensus statement; (3) suffered the initial injury in the previous 48 hours; (4) 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,; 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; 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.

Inclusion criteria. Subjects presenting to one of the study hospital EDs after sustaining a head injury will be eligible if they: (1) are aged 5 to 17 years; (2) have a concussion, defined by Zurich consensus statement; (3) suffered the initial injury in the previous 48 hours; (4) 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,; 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; 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.

Period Title: Overall Study
Started 2006 1057
Completed 1701 883
Not Completed 305 174
Arm/Group Title Derivation Cohort Validation Cohort Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 2006 1057 3063
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 2006 participants 1057 participants 3063 participants
11.8
(8.9 to 14.6)
12.3
(9.6 to 14.8)
12.0
(9.2 to 14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2006 participants 1057 participants 3063 participants
Female
765
  38.1%
440
  41.6%
1205
  39.3%
Male
1241
  61.9%
617
  58.4%
1858
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 2006 participants 1057 participants 3063 participants
2006 1057 3063
1.Primary Outcome
Title Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up.
Hide Description 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).
Time Frame 1 month
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Hide Analysis Population Description
Completed 1-month followup.
Arm/Group Title PPCS in Derivation PPCS in Validation
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August 2013 to September 2014
October 2014 to June 2015
Overall Number of Participants Analyzed 1701 883
Measure Type: Count of Participants
Unit of Measure: Participants
510
  30.0%
291
  33.0%
2.Secondary Outcome
Title Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Completed PedsQL at 1-month post-concussion.
Arm/Group Title Participants With PPCS Participants Without PPCS
Hide Arm/Group Description:
The primary outcome measure, PPCS, was defined in keeping with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) definition of postconcussion syndrome, which requires persistence beyond 4 weeks of at least 3 symptoms compared with state of being prior to the injury. In the study, an individual symptom was defined as a positive difference between the patient-reported current minus the perceived preinjury symptom rating on PCSI; both were completed 28 days after the injury.
Less than 3 symptoms compared with state of being prior to the injury at 28 days. In the study, an individual symptom was defined as a positive difference between the patient-reported current minus the perceived preinjury symptom rating on PCSI; both were completed 28 days after the injury.
Overall Number of Participants Analyzed 510 1157
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
70.0
(67.7 to 72.3)
80.3
(78.1 to 82.6)
3.Secondary Outcome
Title Neuropsychological Evaluation
Hide Description 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.
Time Frame 1 month and 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Participants assessed at 4- and 12-weeks post-injury using direct, standardized measures of intellectual functioning, verbal memory, executive functioning, attention/working memory, processing speed and fine motor abilities.
Arm/Group Title Number of Children With Neuropsychological Impairment
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Incidence of neuropsychological impairment was determined using the Neuropsychological Impairment (NPI) rule (Beauchamp et al., 2015) and multiple hierarchical logistic and linear regressions were performed to assess the contribution of pre-morbid factors, acute symptoms, and acute cognitive testing to neuropsychological impairment and performance.
Overall Number of Participants Analyzed 311
Measure Type: Count of Participants
Unit of Measure: Participants
32
  10.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants
Hide Arm/Group Description All enrolled participants.
All-Cause Mortality
Participants
Affected / at Risk (%)
Total   0/3063 (0.00%) 
Hide Serious Adverse Events
Participants
Affected / at Risk (%)
Total   0/3063 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants
Affected / at Risk (%)
Total   0/3063 (0.00%) 

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.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roger Zemek
Organization: Children's Hospital of Eastern Ontario
Phone: 613-737-7600
EMail: rzemek@cheo.on.ca
Layout table for additonal information
Responsible Party: Roger Zemek, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01873287    
Other Study ID Numbers: CIHR-302955, CIHR-287347
First Submitted: June 6, 2013
First Posted: June 10, 2013
Results First Submitted: April 20, 2018
Results First Posted: November 18, 2019
Last Update Posted: November 18, 2019