An observational study in Mild Traumatic Brain Injury, sponsored by Pediatric Clinical Research Platform. Completed at 1 site in Switzerland. Open to participants aged 0 Months to 16 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Pediatric Clinical Research Platform · Observational
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:
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.
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.
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
This study's enrollment of 600 is above the median of 177 across 151 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →Pediatric Clinical Research Platform is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
paediatric patient suffering from a mild TBI within 24 hours
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children \<16 years-old who suffered a head trauma in the last 24 hours with signs of mild traumatic brain injury
Children \<16 years-old who have a scheduled blood test for any reason
intracranial injuries on CT scan
Hemorrhage, oedema, traumatic infarction, diffuse axonal injury, pneumocephalus
Time frame: Admission; within 24 hours
Post concussion symptoms
Such as persistent headache, fatigue, concentration difficulty etc. Evaluated by a neuropsychologist and results of the PCSI score (post concussion symptoms inventory)
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Jun 2024, 44 months.
Of 67 non-industry observational studies under Brain Concussion, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 188. This study's 44 months is close to that.
Counting every sponsor, half of 87 studies reached it within 36 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Pediatric Clinical Research Platform