George Joanne M, Pagnozzi Alex M, Bora Samudragupta, Boyd Roslyn N, Colditz Paul B, Rose Stephen E, Ware Robert S, Pannek Kerstin, Bursle Jane E, Fripp Jurgen, Barlow Karen, Iyer Kartik, Leishman Shaneen J, Jendra Rebecca L
Child Health Research Centre, Queensland Cerebral Palsy and Rehabilitation Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia
The Australian e-Health Research Centre, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Brisbane, Queensland, Australia.
BMJ Open. 2020 May 12;10(5):e036480. doi: 10.1136/bmjopen-2019-036480.
Infants born very preterm are at risk of adverse neurodevelopmental outcomes, including cognitive deficits, motor impairments and cerebral palsy. Earlier identification enables targeted early interventions to be implemented with the aim of improving outcomes.
Protocol for 6-year follow-up of two cohorts of infants born <31 weeks gestational age (PPREMO: Prediction of Preterm Motor Outcomes; PREBO: Prediction of Preterm Brain Outcomes) and a small term-born reference sample in Brisbane, Australia. Both preterm cohorts underwent very early MRI and concurrent clinical assessment at 32 and 40 weeks postmenstrual age (PMA) and were followed up at 3, 12 and 24 months corrected age (CA). This study will perform MRI and electroencephalography (EEG). Primary outcomes include the Movement Assessment Battery for Children second edition and Full-Scale IQ score from the Wechsler Intelligence Scale for Children fifth edition (WISC-V). Secondary outcomes include the Gross Motor Function Classification System for children with cerebral palsy; executive function (Behavior Rating Inventory of Executive Function second edition, WISC-V Digit Span and Picture Span, Wisconsin Card Sorting Test 64 Card Version); attention (Test of Everyday Attention for Children second edition); language (Clinical Evaluation of Language Fundamentals fifth edition), academic achievement (Woodcock Johnson IV Tests of Achievement); mental health and quality of life (Development and Well-Being Assessment, Autism Spectrum Quotient-10 Items Child version and Child Health Utility-9D).
Examine the ability of early neonatal MRI, EEG and concurrent clinical measures at 32 weeks PMA to predict motor, cognitive, language, academic achievement and mental health outcomes at 6 years CA.Determine if early brain abnormalities persist and are evident on brain MRI at 6 years CA and the relationship to EEG and concurrent motor, cognitive, language, academic achievement and mental health outcomes.
Ethical approval has been obtained from Human Research Ethics Committees at Children's Health Queensland (HREC/19/QCHQ/49800) and The University of Queensland (2019000426). Study findings will be presented at national and international conferences and published in peer-reviewed journals.
ACTRN12619000155190p. WEB ADDRESS OF TRIAL: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000155190p.
极早产儿有出现不良神经发育结局的风险，包括认知缺陷、运动障碍和脑瘫。早期识别有助于实施有针对性的早期干预，以改善结局。
对澳大利亚布里斯班两个胎龄小于31周的婴儿队列（PPREMO：早产运动结局预测；PREBO：早产脑结局预测）以及一个足月儿参考样本进行为期6年的随访方案。两个早产队列在孕龄32周和40周时均接受了极早期MRI检查和同步临床评估，并在矫正年龄3个月、12个月和24个月时进行随访。本研究将进行MRI和脑电图（EEG）检查。主要结局包括儿童运动评估量表第二版以及韦氏儿童智力量表第五版（WISC-V）的全量表智商得分。次要结局包括脑瘫儿童的粗大运动功能分类系统；执行功能（执行功能行为评定量表第二版、WISC-V数字广度和图片广度、威斯康星卡片分类测验64卡片版）；注意力（儿童日常注意力测试第二版）；语言（语言基本能力临床评估第五版）、学业成绩（伍德科克-约翰逊IV成就测验）；心理健康和生活质量（发育与幸福感评估、儿童版自闭症谱系商数10项和儿童健康效用-9D）。
研究孕龄32周时早期新生儿MRI、EEG及同步临床测量对矫正年龄6岁时运动、认知、语言、学业成绩和心理健康结局的预测能力。确定早期脑异常在矫正年龄6岁时是否持续存在且在脑MRI上是否明显，以及其与EEG及同步运动、认知、语言、学业成绩和心理健康结局的关系。
已获得昆士兰儿童健康人类研究伦理委员会（HREC/19/QCHQ/49800）和昆士兰大学（2019000426）的伦理批准。研究结果将在国内和国际会议上展示，并发表在同行评审期刊上。
ACTRN12619000155190p。试验网址：http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000155190p。
