N/A
N=3,063
Predicting Persistent Postconcussive Problems in Pediatrics (5P)
Concussions · PCS
Bottom Line
View on ClinicalTrials.gov: NCT01873287 ↗Enrolled (actual)
3,063
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. — 510; 291 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Eastern Ontario
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. |
510; 291 | — |
| SECONDARY Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury |
70.0; 80.3 | — |
| SECONDARY Neuropsychological Evaluation |
32 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01873287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.