Quantifying Brain Injury on Computed Tomography in Hospitalized Children: a Prospective Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 425
- 主要终点
- To measure if QBIct predicts the development of new cerebral dysfunction measured on the Glasgow Outcome Scale Extended for Pediatrics score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Non hospitalized
- •Non traumatic brain injury
结局指标
主要结局
To measure if QBIct predicts the development of new cerebral dysfunction measured on the Glasgow Outcome Scale Extended for Pediatrics score
时间窗: 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
次要结局
- To determine if QBIct tool predicts secondary clinical outcomes(90 days)
- To determine if QBIct tool predicts recovery endpoints.(90 days)
研究者
Anne-Marie Guerguerian
Senior Scientist
The Hospital for Sick Children