About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Diagnosis of previous TBI (any severity, any age)
Intentional injury,
Administration of sedative drugs that can alter brain function
Complications following injury
Trial 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))
Trial design
Case-control
Prospective
Treatments tested in this trial
IRM exam
Other interventionA non-sedated MRI scan will be performed to assess the structure and function of the children's brains
Treatment groups
Trial outcomes
Primary outcomes
Persistent brain structure alterations
Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
Secondary outcomes
Persistent brain lesions - Volume
Volume of brain lesions measured with susceptibility MRI
Persistent brain lesions - Number
Number brain lesions measured with susceptibility MRI
Cerebral blood flow alteration
Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)
Functional integrity of brain networks
Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI
Other outcomes
Acute and persistent post-concussive symptoms
Assessment of post-concussive symptoms using the REACTIONS questionnaire
Persistent behavioural difficulties
Assessment of behaviour using the Strengths and Difficulties Questionnaire
Sponsors and contacts
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Institut National de la Santé Et de la Recherche Médicale, France
Lead sponsor
Institut National de Recherche en Informatique et en Automatique
Collaborator