Status:
RECRUITING
Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Institut National de Recherche en Informatique et en Automatique
Conditions:
TBI (Traumatic Brain Injury)
Eligibility:
All Genders
36-71 years
Brief Summary
Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact conseque...
Eligibility Criteria
Inclusion
- Patient group with mild traumatic brain injury (mTBI) :
- Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
- Presentation to the emergency department within 48 hours post-injury
- Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury
- Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria)
- Control group with orthopaedic injury:
- Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
- Presentation to the emergency department within 48 hours post-injury
- Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb
- Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild).
Exclusion
- Diagnosis of previous TBI (any severity, any age)
- Intentional injury,
- Administration of sedative drugs that can alter brain function
- Complications following injury
- MRI contraindication,
- Parent non-fluent in French,
- Prematurity,
- Diagnosis of a severe neurological, developmental, or psychiatric disorder
- Children in foster care at the time of recruitment
Key Trial Info
Start Date :
July 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06024122
Start Date
July 3 2024
End Date
December 1 2026
Last Update
February 10 2025
Active Locations (1)
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1
Unité des urgences médicochirurgicales CHU Rennes
Rennes, France, 35200