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临床试验/NCT06233851
NCT06233851已完成不适用

Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms

Pediatric Clinical Research Platform1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
intracranial injuries on CT scan

研究概览

简要总结

The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:

  1. How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
  2. How can blood biomarker predict post-concussion symptoms?

Participants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.

详细描述

Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome.

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
0 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • mTBI within 24 hours

排除标准

  • refusal of child or parents
  • evidence of intoxication with alcohol or other substances
  • history of TBI ( less than one month)
  • epilepsy, encephalitis, meningitis, melanoma

结局指标

主要结局

intracranial injuries on CT scan

时间窗: Admission; within 24 hours

Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus

Post concussion symptoms

时间窗: 3 months

Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)

次要结局

未报告次要终点

研究者

发起方
Pediatric Clinical Research Platform
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio MANZANO

professor

Pediatric Clinical Research Platform

研究点 (1)

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