Midazolam oral solution for neonatal MRI: study protocol of a randomised controlled trial

INTRODUCTION: Current medications used for neonatal MRI sedation may lead to complications such as decreased oxygen saturation, apnoea and bradycardia. There has been no study investigating the application of midazolam oral solution in neonatal MRI examinations. Therefore, this study aims to observe the safety and efficacy of midazolam oral solution for sedation during neonatal MRI examinations, providing a reference for clinical application. METHODS AND ANALYSIS: We designed a double-blind randomised controlled trial. A total of 140 neonates who underwent MRI are included. The neonates are randomly assigned into two groups of n=70 each to receive either midazolam oral solution or chloral hydrate oral solution. The primary outcome indicator of the study is the success rate of sedation as assessed by the University of Michigan Sedation Scale (UMSS). In addition, the time to a UMSS score of 2 or greater after drug administration, the number of sedation remedies, the behavioural scores of the children while taking the drug and the movement scores during the MRI performed are collected as secondary outcome indicators. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained from the Ethics Committee of the Chengdu Women's and Children's Central Hospital (Approval No. 2023 (18)-2). The study findings will be submitted for peer-reviewed publication in a scientific journal. TRIAL REGISTRATION NUMBER: ChiCTR2300069996.