Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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 consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes. The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging. In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 5
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Unité des urgences médicochirurgicales CHU Rennes
RECRUITING
Rennes
Contact Information
Primary
Fanny DÉGEILH, PhD
fanny.degeilh@inserm.fr
+33 2 99 84 71 63
Backup
Véronique CHASLE, MD
veronique.chasle@chu-rennes.fr
+33 2 99 26 67 58
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Patients with a mTBI
Children with a mTBI aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.
Control with an orthopaedic injury
Children with an orthopaedic injury aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.
Related Therapeutic Areas
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Institut National de Recherche en Informatique et en Automatique

This content was sourced from clinicaltrials.gov