Queensland Cerebral Palsy and Rehabilitation Research Centre, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia
Townsville Hospital and Health Service, Townsville, Queensland, Australia.
BMJ Open. 2022 Jan 7;12(1):e053646. doi: 10.1136/bmjopen-2021-053646.
Neurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are 'at risk' of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants 'at risk' of a later diagnosis of adverse NDO or NDD will be determined.
Aboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020-2022) will be invited to participate. Infants aged 9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or 'at risk' of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.
Ethics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children's Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.
ACTRN12619000969167.
神经发育障碍(NDD),包括脑瘫(CP)、自闭症谱系障碍(ASD)和胎儿酒精谱系障碍(FASD),其特征是早期中枢神经系统发育受损,影响认知和/或身体功能。早期发现 NDD 可以使婴儿快速进入早期干预服务,从而优化结果。原住民和托雷斯海峡岛民婴儿可能经历增加神经发育脆弱性风险的生命早期因素,这些因素会持续到儿童后期,进一步加剧澳大利亚原住民人民面临的健康不平等。LEAP-CP 前瞻性队列研究将调查澳大利亚昆士兰州实施的早期筛查计划的疗效,以更早地识别出有不良神经发育结局(NDO)或 NDD 风险的原住民和托雷斯海峡岛民婴儿。将确定用于识别有不良 NDO 或 NDD 后期诊断风险的“高危”婴儿的早期检测工具的诊断准确性和可行性。
将邀请出生于澳大利亚昆士兰州(2020-2022 年出生年份)的原住民和/或托雷斯海峡岛民婴儿参加。9 个月校正年龄(CA)的婴儿将使用(1)一般运动评估(GMA);(2)哈默史密斯婴儿神经检查(HINE);(3)快速神经发育评估(RNDA)和(4)年龄和阶段问卷-原住民改编版(ASQ-TRAK)进行筛查。将在 12 个月 CA 时确定发育结果:(1)神经(HINE);(2)运动(Peabody 发育运动量表 2);(3)认知和沟通(贝利婴儿发育量表 III);(4)功能能力(小儿残疾评估量表-计算机自适应测试)和(5)行为(婴儿-学步儿社会和情感评估)。将根据症状使用发育和诊断结果将婴儿分类为发育正常或“有不良 NDO 和/或特定 NDD 风险”:(1)CP(2)ASD 和(3)FASD。将调查围产期、社会和环境因素、照顾者心理健康和临床神经影像学对 NDO 的影响。
已获得昆士兰州相关伦理委员会的批准;远北昆士兰健康研究伦理委员会(HREC/2019/QCH/50533(Sep ver 2)-1370)、汤斯维尔 HHS 人类研究伦理委员会(HREC/QTHS/56008)、昆士兰大学医学研究伦理委员会(2020000185/HREC/2019/QCH/50533)和昆士兰儿童健康 HHS 人类研究伦理委员会(HREC/20/QCHQ/63906),并得到当地原住民社区的治理和支持。这项研究的结果将通过同行评议的出版物和会议报告进行传播。
ACTRN12619000969167。