Examining brain development in young children after mild traumatic brain injury
Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
This study is trying to see how mild concussions affect the brains and behavior of young children aged 3 to 5 compared to kids with other types of injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 36 Months to 71 Months |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Rennes) |
| Trial ID | NCT06024122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of mild traumatic brain injury (mTBI) on brain structure, function, and behavior in children aged 3 to 5 years. By comparing a group of 30 children who have sustained a concussion with another group of 30 children who have experienced an orthopedic injury, researchers will utilize brain imaging techniques to assess potential differences. The study seeks to enhance understanding of how concussions affect young children's developing brains, which may differ significantly from older children. The findings could provide valuable insights into the long-term consequences of mTBI in early childhood.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 5 years who have recently sustained a mild traumatic brain injury or an orthopedic injury.
Not a fit: Patients with a history of previous traumatic brain injury or those with intentional injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of concussions in young children, potentially guiding better treatment and prevention strategies.
How similar studies have performed: While there is ongoing research into the effects of concussions in children, this specific approach comparing mTBI with orthopedic injuries in very young children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient group with mild traumatic brain injury (mTBI) : 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury 4. Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria) * Control group with orthopaedic injury: 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) 2. Presentation to the emergency department within 48 hours post-injury 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb 4. Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild). Exclusion Criteria: * 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
Where this trial is running
Rennes
- Unité des urgences médicochirurgicales CHU Rennes — Rennes, France (Recruiting)
Study contacts
- Study coordinator: Fanny DÉGEILH, PhD
- Email: fanny.degeilh@inserm.fr
- Phone: +33 2 99 84 71 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.