Trauma, BrainQBIctNCT04176640
Quantifying Brain Injury on Computed Tomography in Hospitalized Children
An observational study of Trauma, Brain and Pediatric, run by The Hospital for Sick Children.
Trial summary
Lay Summary: To evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury. The Problem: Children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Trauma, Brain, Pediatric
- How many people
- 425 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized children with traumatic brain injury
Who may be able to join
- Hospitalized with TBI
- Age: less than 18 years of age who undergoes routine head CT in the acute period with any severity of injury based on Glasgow Coma Scale score (3 to15).
Who cannot join
- Non hospitalized
- Non traumatic brain injury
About this study
Official title: Quantifying Brain Injury on Computed Tomography in Hospitalized Children: a Prospective Trial
Lay Summary:
To evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury.
Read more
The Problem: Children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. Unfortunately, history and physical findings are often unreliable in the first hours after hospitalization, the period in which urgent management decisions must be made for their treatment.
The Solution: A promising tool developed for measuring detectable evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.
Read the detailed description
To evaluate a novel early neuroimaging diagnostic tool for hospitalized children with traumatic brain injury.
This tool is used to detect evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.
- Conditions
- Trauma, Brain, Pediatric
- Keywords
- pediatric traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure if QBIct predicts the development of new cerebral dysfunction measured on the Glasgow Outcome Scale Extended for Pediatrics score
GOSE for Pediatrics score is the reference standard for measuring traumatic brain injury (TBI) outcome. GOSE-P is a NINDS Common Data Element for functional outcome that rates patient status into one of eight categories: Dead, Vegetative State, Lower severe disability, Upper severe Disability, Lower moderate disability, Upper moderate Disability, Lower good recovery or Upper good Recovery. Minimum score = 1, Maximum score = 8
Level 1 = Dead Level 2 = Vegetative State Level 3 = Low Severe Disability Level 4 = Upper Severe Disability Level 5 = Lower Moderate Disability Level 6 = Upper Moderate Disability Level 7 = Low Good Recovery Level 8 = Upper Good Recovery
Measured: 30 days
Secondary outcomes (2)
To determine if QBIct tool predicts secondary clinical outcomes
Clinical outcomes were defined as intracranial hypertension and/or, need for neurosurgical intervention and/or early mortality.
Measured: 90 days
To determine if QBIct tool predicts recovery endpoints.
Endpoints were defined by global functional outcomes, mechanical ventilation days, and intensive care days, hospital days and/or home from school days.
Global functional outcomes will be measured using Vineland-II. Vineland-II is a standardized psychological tool used to measure 4 major aspects of adaptive functioning: Communication, Daily Living Skills, Socialization and Motor Skills. It measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do.
In order to determine the level of an individual's adaptive behavior, someone who is familiar with that individual, such as a parent or caregiver, is asked to describe his activities. Those activities are then compared to those of ot
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 Oct 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, BrainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Anne-Marie Guerguerian, The Hospital for Sick Children
- Investigators
- Anne-Marie Guerguerian, Principal investigator, The Hospital for Sick Children, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176640
- Sponsor's protocol ID
- REB1000050054
- Acronym
- QBIct
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Brain Injury on Computed Tomography in Hospitalized Children: a Prospective Trial
- ClinicalTrials.gov ID
- NCT04176640
- Acronym / sponsor ID
- QBIct / REB1000050054
- Conditions
- Trauma, Brain, Pediatric
- Keywords
- pediatric traumatic brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 425 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lay Summary:
To evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury.
The Problem: Children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. Unfortunately, history and physical findings are often unreliable in the first hours after hospitalization, the period in which urgent management decisions must be made for their treatment.
The Solution: A promising tool developed for measuring detectable evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.
Detailed description
To evaluate a novel early neuroimaging diagnostic tool for hospitalized children with traumatic brain injury.
This tool is used to detect evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized children with traumatic brain injury
Key inclusion criteria (2 listed)
- Hospitalized with TBI
- Age: less than 18 years of age who undergoes routine head CT in the acute period with any severity of injury based on Glasgow Coma Scale score (3 to15).
Key exclusion criteria (2 listed)
- Non hospitalized
- Non traumatic brain injury
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
To measure if QBIct predicts the development of new cerebral dysfunction measured on the Glasgow Outcome Scale Extended for Pediatrics score
Time frame: 30 days
GOSE for Pediatrics score is the reference standard for measuring traumatic brain injury (TBI) outcome. GOSE-P is a NINDS Common Data Element for functional outcome that rates patient status into one of eight categories: Dead, Vegetative State, Lower severe disability, Upper severe Disability, Lower moderate disability, Upper moderate Disability, Lower good recovery or Upper good Recovery. Minimum score = 1, Maximum score = 8 Level 1 = Dead Level 2 = Vegetative State Level 3 = Low Severe Disability Level 4 = Upper Severe Disability Level 5 = Lower Moderate Disability Level 6 = Upper Moderate Disability Level 7 = Low Good Recovery Level 8 = Upper Good Recovery
2 secondary outcomes
To determine if QBIct tool predicts secondary clinical outcomes
Time frame: 90 days
To determine if QBIct tool predicts recovery endpoints.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- QBI CT Web SiteLink provided by the sponsor.
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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.
Anne-Marie Guerguerian principal investigator
The Hospital for Sick Children, University of Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Brain and Pediatric, run by The Hospital for Sick Children.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To measure if QBIct predicts the development of new cerebral dysfunction measured on the Glasgow Outcome Scale Extended for Pediatrics score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2019.