新生儿惊厥智能诊疗系统真实场景临床实施效果综合评价的多中心临床研究方案

Evaluation of the clinical effect of an artificial intelligence-assisted diagnosis andtreatment system for neonatal seizures in the real world: a multicenter clinical studyprotocol

摘要:

新生儿惊厥作为新生儿危重症中最常见的临床表现，常提示严重疾病且病因复杂。其精准的诊断不仅可以优化抗惊厥药物的使用、节约住院费用，同时有望改善患儿神经系统远期发育。目前已有新生儿惊厥智能诊疗系统，但其在真实临床场景实施中的诊疗价值尚缺乏高级证据。基于已开发的新生儿惊厥智能诊疗系统，该研究拟在全国6个新生儿重症监护单元招募370名新生儿惊厥高危患儿，评估该系统在真实新生儿重症监护单元中对不同胎龄新生儿惊厥的诊断、治疗及预后的作用。该研究将采用诊断性研究方案评估该系统的诊断价值，以及采用随机化平行对照试验设计评估该系统对惊厥高危患儿临床疗效和预后的作用。该多中心前瞻性研究将为新生儿惊厥智能诊疗系统在真实临床场景中的实施效果提供证据。

Abstract:

Neonatal seizures are the most common clinical manifestations of critically ill neonates and often suggest serious diseases and complicated etiologies.The precise diagnosis of this disease can optimize the use of anti-seizure medication,reduce hospital costs,and improve the long-term neurodevelopmental outcomes.Currently,a few artificial intelligence-assisted diagnosis and treatment systems have been developed for neonatal seizures,but there is still a lack of high-level evidence for the diagnosis and treatment value in the real world.Based on an artificial intelligence-assisted diagnosis and treatment systems that has been developed for neonatal seizures,this study plans to recruit 370 neonates at a high risk of seizures from 6 neonatal intensive care units(NICUs)in China,in order to evaluate the effect of the system on the diagnosis,treatment,and prognosis of neonatal seizures in neonates with different gestational ages in the NICU.In this study,a diagnostic study protocol is used to evaluate the diagnostic value of the system,and a randomized parallel-controlled trial is designed to evaluate the effect of the system on the treatment and prognosis of neonates at a high risk of seizures.This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.