Beauchamp Miriam H, Dégeilh Fanny, Yeates Keith, Gagnon Isabelle, Tang Ken, Gravel Jocelyn, Stang Antonia, Burstein Brett, Bernier Annie, Lebel Catherine, El Jalbout Ramy, Lupien Sonia, de Beaumont Louis, Zemek Roger, Dehaes Mathieu, Deschênes Sylvain
Psychology, Université de Montréal, Montreal, Quebec, Canada
Sainte-Justine Hospital Research Center, Montreal, Quebec, Canada.
BMJ Open. 2020 Oct 19;10(10):e040603. doi: 10.1136/bmjopen-2020-040603.
Mild traumatic brain injury (mTBI) is highly prevalent, especially in children under 6 years. However, little research focuses on the consequences of mTBI early in development. The objective of the Kids' Outcomes And Long-term Abilities (KOALA) study is to document the impact of early mTBI on children's motor, cognitive, social and behavioural functioning, as well as on quality of life, stress, sleep and brain integrity.
KOALA is a prospective, multicentre, longitudinal cohort study of children aged 6 months to 6 years at the time of injury/recruitment. Children who sustain mTBI (n=150) or an orthopaedic injury (n=75) will be recruited from three paediatric emergency departments (PEDs), and compared with typically developing children (community controls, n=75). A comprehensive battery of prognostic and outcome measures will be collected in the PED, at 10 days, 1, 3 and 12 months postinjury. Biological measures, including measures of brain structure and function (magnetic resonance imaging, MRI), stress (hair cortisol), sleep (actigraphy) and genetics (saliva), will complement direct testing of function using developmental and neuropsychological measures and parent questionnaires. Group comparisons and predictive models will test the a priori hypotheses that, compared with children from the community or with orthopaedic injuries, children with mTBI will (1) display more postconcussive symptoms and exhibit poorer motor, cognitive, social and behavioural functioning; (2) show evidence of altered brain structure and function, poorer sleep and higher levels of stress hormones. A combination of child, injury, socioenvironmental and psychobiological factors are expected to predict behaviour and quality of life at 1, 3 and 12 months postinjury.
The KOALA study is approved by the Sainte-Justine University Hospital, McGill University Health Centre and University of Calgary Conjoint Health Research Ethics Boards. Parents of participants will provide written consent. Dissemination will occur through peer-reviewed journals and an integrated knowledge translation plan.
轻度创伤性脑损伤（mTBI）非常普遍，尤其是在6岁以下的儿童中。然而，很少有研究关注mTBI在发育早期的后果。儿童结局与长期能力（KOALA）研究的目的是记录早期mTBI对儿童运动、认知、社交和行为功能以及生活质量、压力、睡眠和脑完整性的影响。
KOALA是一项针对受伤/入组时年龄在6个月至6岁儿童的前瞻性、多中心、纵向队列研究。将从三个儿科急诊科（PEDs）招募遭受mTBI的儿童（n = 150）或骨科损伤的儿童（n = 75），并与正常发育儿童（社区对照组，n = 75）进行比较。在PED、受伤后10天、1、3和12个月时，将收集一系列全面的预后和结局指标。生物学指标，包括脑结构和功能测量（磁共振成像，MRI）、压力（头发皮质醇）、睡眠（活动记录仪）和遗传学（唾液），将补充使用发育和神经心理学测量以及家长问卷对功能进行的直接测试。组间比较和预测模型将检验先验假设，即与社区儿童或骨科损伤儿童相比，mTBI儿童将（1）表现出更多的脑震荡后症状，并且运动、认知、社交和行为功能更差；（2）显示出脑结构和功能改变、睡眠较差以及应激激素水平较高的证据。预计儿童、损伤、社会环境和心理生物学因素的组合将预测受伤后1、3和12个月的行为和生活质量。
KOALA研究已获得圣贾斯汀大学医院、麦吉尔大学健康中心和卡尔加里大学联合健康研究伦理委员会批准。参与者的父母将提供书面同意书。研究结果将通过同行评审期刊和综合知识转化计划进行传播。
