Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study
Prediction of adverse motor outcome for neonates with punctate white matter lesions by MRI images using radiomics strategy: protocol for a prospective cohort multicentre study
复制标题
使用放射组学策略通过 MRI 图像预测点状白质病变新生儿的不良运动结果：前瞻性队列多中心研究方案
DOI：
10.1136/bmjopen-2018-023157
复制
发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Yang，Jian
中科院分区：
文献类型：
--
作者：
Wang，Miaomiao;Liu，Heng;Yang，Jian
点状白色病变（PWML）是早产儿常见的白色病变，可引起运动障碍甚至脑瘫。然而，导致不良运动结果的病变的基于个体的精确诊断仍不清楚，迫切需要一种有效的方法来指导临床诊断和治疗。多模态数据的先进放射组学可以提供生物标志物的可能性，并定量确定预后。该研究旨在开发和验证一种模型，用于预测PWML新生儿在校正年龄（CA）为24个月时的不良运动结局。方法和分析一项前瞻性队列多中心研究将在11家中国医院进行。共有394名经MRI证实患有PWML的新生儿将接受临床评估（改良的新生儿行为评估量表）。在18个月的CA时，将通过Bayley婴幼儿发育量表-III（Bayley-III）评估运动功能。将在24个月的CA时使用Bayley-III和粗大运动功能分类系统确认轻度至重度运动障碍。在数据收集期间，还将记录围产期和临床信息。根据放射组学策略，将提取的影像学特征和临床信息结合起来进行探索性分析。在使用多重建模方法后，将计算准确度、灵敏度和特异性。内部和外部确认将用于评价放射组学模型的性能。伦理与传播本研究已获得西安交通大学第一附属医院伦理审查委员会批准（XJTU 1AF 2015 LSK-172）。将向合格受试者的所有父母提供研究的详细说明，并将获得书面同意。这项研究的结果将发表在同行评审的期刊上，并在地方，国家和国际会议上发表。试验注册号NCT 02637817;预结果。
Introduction Punctate white matter lesions (PWML) are prevalent white matter disease in preterm neonates, and may cause motor disorders and even cerebral palsy. However, precise individual-based diagnosis of lesions that result in an adverse motor outcome remains unclear, and an effective method is urgently needed to guide clinical diagnosis and treatment. Advanced radiomics for multiple modalities data can provide a possible look for biomarkers and determine prognosis quantitatively. The study aims to develop and validate a model for prediction of adverse motor outcomes at a corrected age (CA) of 24 months in neonates with PWML. Methods and analysis A prospective cohort multicentre study will be conducted in 11 Chinese hospitals. A total of 394 neonates with PWML confirmed by MRI will undergo a clinical assessment (modified Neonatal Behavioural Assessment Scale). At a CA of 18 months, the motor function will be assessed by Bayley Scales of Infant and Toddler Development-III (Bayley-III). Mild-to-severe motor impairments will be confirmed using the Bayley-III and Gross Motor Function Classification System at a CA of 24 months. During the data collection, the perinatal and clinical information will also be recorded. According to the radiomics strategy, the extracted imaging features and clinical information will be combined for exploratory analysis. After using multiple-modelling methodology, the accuracy, sensitivity and specificity will be computed. Internal and external validations will be used to evaluate the performance of the radiomics model. Ethics and dissemination This study has been approved by the institutional review board of The First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2015LSK-172). All parents of eligible participants will be provided with a detailed explanation of the study and written consent will be obtained. The results of this study will be published in peer-reviewed journals and presented at local, national and international conferences. Trial registration number NCT02637817; Pre-results.