Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Persistent brain structure alterations
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 36 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: IRM exam (Other)
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.
干预措施: IRM exam (Other)
结局指标
主要结局
Persistent brain structure alterations
时间窗: 3 months post-injury
Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
次要结局
- Functional integrity of brain networks(3 months post-injury)
- Structural integrity of brain networks(3 months post-injury)
- Persistent brain lesions - Volume(3 months post-injury)
- Persistent brain lesions - Number(3 months post-injury)
- Cerebral blood flow alteration(3 months post-injury)