Trial · NCT01873287
Predicting Persistent Postconcussive Problems in Pediatrics (5P)
NCT01873287, Completed, Children's Hospital of Eastern Ontario; results first posted 2019-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Predicting Persistent Postconcussive Problems in Pediatrics (5P). Trials, record NCT01873287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01873287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Predicting Persistent Postconcussive Problems in Pediatrics (5P)
- NCT number
- NCT01873287
- Status
- Completed
- Enrollment
- 3,063 participants, actual
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Conditions
- Concussions, PCS
- First posted
- 2013-06-10
- Last updated
- 2019-11-18
- Results first posted
- 2019-11-18
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. | 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). |
| Secondary | Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury | 1 month | 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. |
| Secondary | Neuropsychological Evaluation | 1 month and 3 month | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. | 1 month | Completed 1-month followup. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury | 1 month | Completed PedsQL at 1-month post-concussion. | units on a scale | MEAN |
| SECONDARY | Neuropsychological Evaluation | 1 month and 3 month | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. | PPCS in Derivation | 510 | Participants | ||
| Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. | PPCS in Validation | 291 | Participants | ||
| Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury | Participants With PPCS | 70.0 | 95% Confidence Interval 67.7 to 72.3 | units on a scale | |
| Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury | Participants Without PPCS | 80.3 | 95% Confidence Interval 78.1 to 82.6 | units on a scale | |
| Neuropsychological Evaluation | Number of Children With Neuropsychological Impairment | 32 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Derivation Arm | 2,006 | |
| Overall Study | STARTED | Validation Arm | 1,057 | |
| Overall Study | COMPLETED | Derivation Arm | 1,701 | |
| Overall Study | COMPLETED | Validation Arm | 883 | |
| Overall Study | NOT COMPLETED | Derivation Arm | 305 | |
| Overall Study | NOT COMPLETED | Validation Arm | 174 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants | 0 | 3,063 |
| Total, other adverse events | Participants | 0 | 3,063 |
| Total, serious adverse events | Participants | 0 | 3,063 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PPCS in Derivation vs PPCS in Validation: Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up. |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01873287
GET https://conductscience.org/api/trials/v1/NCT01873287/registered