Trial Outcomes & Findings for Predicting Persistent Postconcussive Problems in Pediatrics (5P) (NCT NCT01873287)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

3063 participants

Primary outcome timeframe

1 month

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Derivation Arm 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.	Validation Arm 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.
Overall Study STARTED	2006	1057
Overall Study COMPLETED	1701	883
Overall Study NOT COMPLETED	305	174

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predicting Persistent Postconcussive Problems in Pediatrics (5P)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Derivation Cohort n=2006 Participants	Validation Cohort n=1057 Participants	Total n=3063 Participants Total of all reporting groups
Age, Continuous	11.8 years n=5 Participants	12.3 years n=7 Participants	12.0 years n=5 Participants
Sex: Female, Male Female	765 Participants n=5 Participants	440 Participants n=7 Participants	1205 Participants n=5 Participants
Sex: Female, Male Male	1241 Participants n=5 Participants	617 Participants n=7 Participants	1858 Participants n=5 Participants
Region of Enrollment Canada	2006 participants n=5 Participants	1057 participants n=7 Participants	3063 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Completed 1-month followup.

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).

Outcome measures

Outcome measures
Measure	PPCS in Derivation n=1701 Participants August 2013 to September 2014	PPCS in Validation n=883 Participants October 2014 to June 2015
Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up.	510 Participants	291 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Completed PedsQL at 1-month post-concussion.

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.

Outcome measures

Outcome measures
Measure	PPCS in Derivation n=510 Participants August 2013 to September 2014	PPCS in Validation n=1157 Participants October 2014 to June 2015
Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury	70.0 units on a scale Interval 67.7 to 72.3	80.3 units on a scale Interval 78.1 to 82.6

SECONDARY outcome

Timeframe: 1 month and 3 month

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PPCS in Derivation n=311 Participants August 2013 to September 2014	PPCS in Validation October 2014 to June 2015
Neuropsychological Evaluation	32 Participants	—

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roger Zemek

Children's Hospital of Eastern Ontario

Phone: 613-737-7600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place