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

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.