Quantifying Brain Injury on Computed Tomography in Hospitalized Children

NCT04176640 | Unknown

• 1 other identifier: REB1000050054
• Study Type: observational
• Target: 425
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Trauma, Brain; Pediatric

Keywords

pediatric traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (2)

• To determine if QBIct tool predicts secondary clinical outcomes

  90 days

• To determine if QBIct tool predicts recovery endpoints.

  90 days

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized children with traumatic brain injury

You may qualify if:

• 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).

You may not qualify if:

• Non hospitalized
• Non traumatic brain injury

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Related Links

• QBI CT Web Site

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Anne-Marie Guerguerian

  The Hospital for Sick Children, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 25, 2019
• Study Start: October 20, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11