Clinical trial NCT06024122: Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Official title: Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: TBI (Traumatic Brain Injury)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
First posted: 2023-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) with mTBI.

Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday) with orthopaedic injury (simple fracture, sprain, contusion or unspecified trauma to a limb (mild))

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 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 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

Primary outcomes:
measure: Persistent brain structure alterations
timeFrame: 3 months post-injury
Secondary outcomes:
measure: Persistent brain lesions - Volume
timeFrame: 3 months post-injury
measure: Persistent brain lesions - Number
timeFrame: 3 months post-injury
measure: Cerebral blood flow alteration
timeFrame: 3 months post-injury
measure: Functional integrity of brain networks
timeFrame: 3 months post-injury
measure: Structural integrity of brain networks
timeFrame: 3 months post-injury
Other outcomes:
measure: Acute and persistent post-concussive symptoms
timeFrame: Through study completion, an average of 3 months
measure: Persistent behavioural difficulties
timeFrame: 3 months post-injury
Locations:
city: Rennes
country: France
facility: Unité des urgences médicochirurgicales CHU Rennes
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Fanny DÉGEILH, PhD
role: STUDY_DIRECTOR
References: