Actively Recruiting

Age: 36Months - 71Months
All Genders
NCT06024122

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

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-03-05

60

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

Sponsors

I

Institut National de la Santé Et de la Recherche Médicale, France

Lead Sponsor

I

Institut National de Recherche en Informatique et en Automatique

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 36Months - 71Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 after injury
  • For patient group: documented unintentional non-penetrating head injury and diagnosis of mild traumatic brain injury (WHO pediatric criteria)
  • For control group: documented unintentional trauma to an upper or lower limb and diagnosis of simple fracture, sprain, contusion, or mild unspecified limb trauma
Not Eligible

You will not qualify if you...

  • Previous traumatic brain injury of any severity or age
  • Intentional injury
  • Use of sedative drugs affecting brain function
  • Complications following injury
  • Contraindications for MRI
  • Parent not fluent in French
  • Prematurity
  • Severe neurological, developmental, or psychiatric disorders
  • Child in foster care at recruitment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Unité des urgences médicochirurgicales CHU Rennes

Rennes, France, 35200

Actively Recruiting

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Research Team

F

Fanny DÉGEILH, PhD

CONTACT

V

Véronique CHASLE, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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