Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- Pediatric Clinical Research Platform
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- intracranial injuries on CT scan
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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:
- How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
- 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.
Detailed Description
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.
Investigators
Sergio MANZANO
professor
Pediatric Clinical Research Platform
Eligibility Criteria
Inclusion Criteria
- •mTBI within 24 hours
Exclusion Criteria
- •refusal of child or parents
- •evidence of intoxication with alcohol or other substances
- •history of TBI ( less than one month)
- •epilepsy, encephalitis, meningitis, melanoma
Outcomes
Primary Outcomes
intracranial injuries on CT scan
Time Frame: Admission; within 24 hours
Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus
Post concussion symptoms
Time Frame: 3 months
Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)