A Multi-centre, Randomised, Controlled, Clinical Investigation of a Standalone Decision Support Algorithm for Neonatal Seizure Recognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 8
- 主要终点
- The Seizure Detection Rate for all Neonates enrolled in the investigation arm compared to Seizure Detection Rate for all Neonates in the control arm.
研究概览
简要总结
The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.
详细描述
This will be an open, two arm, parallel group, randomised, controlled investigation of the ANSeR Software System as a stand-alone neonatal seizure recognition decision support tool. Term neonates requiring EEG monitoring will be stratified by recruiting site and then randomised to receive either EEG monitoring with the ANSeR Software System or EEG monitoring without the ANSeR Software System.
It is proposed that the rate of true detections (sensitivity) of investigation personnel using the ANSeR Software System in clinical practice will be at least 25% higher than that of investigation personnel not using the ANSeR Software System in routine clinical practice. In addition we expect the specificity of investigation personnel using the ANSeR Software System to be no worse than 10% less than that of investigation personnel not using the ANSeR Software System. This should result in more appropriate and timely use of antiepileptic drugs (AED).
Randomisation Immediately following enrolment in the investigation, each participant will be randomly assigned to receive either EEG monitoring with the ANSeR Software System or without the ANSeR Software System. Randomisation will be stratified by recruiting site with a 1:1 allocation ratio to each group. Block randomisation with varying block sizes will be used and the randomisation and allocation will be performed centrally using a web-based electronic system.
Blinding As this is an investigation of a medical device (software), the investigation personnel will be aware of which group the participant is assigned to. The expert panel who are the diagnostic reference standard will be blinded to group allocation. The biostatistician will also be blinded to group allocation during the analysis of the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 36 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates 36 weeks - 44 weeks corrected gestational age in whom EEG monitoring is indicated because they are deemed to be
- •at high risk of seizures or
- •are experiencing seizures
排除标准
- •• No parental/guardian consent
研究组 & 干预措施
non ANSeR Software System
Routine clinical EEG monitoring
ANSeR Software System
The intended use of the ANSeR Software System is to provide a real time decision support tool to assist in the diagnosis of seizures in neonates (between 36 weeks and 44 weeks corrected age) and to provide a review tool for EEG and seizure analysis. ANSeR is intended to provide a reliable, effective, objective and intuitive means of identifying seizures
干预措施: ANSeR Software System (Device)
结局指标
主要结局
The Seizure Detection Rate for all Neonates enrolled in the investigation arm compared to Seizure Detection Rate for all Neonates in the control arm.
时间窗: 12-18 months
The rate of true seizure detection (sensitivity), as recorded on a Seizure Record form, 25% superior in the investigation arm compared to the control group (usual clinical practice). The Expert Committee will be used as the diagnostic reference standard.
The False Detections per hour (sensitivity) for all Neonates enrolled in the investigation arm compared to the False Detection Rate for all Neonates in the control arm.
时间窗: 12-18 months
The False Detections per hour (specificity), as recorded on a Seizure Record form, 10% superior in the investigation arm compared to the control group (usual clinical practice). The Expert Committee will be used as the diagnostic reference standard.
次要结局
- Seizure burden (min) for all Neonates enrolled in the investigation arm compared to Seizure burden (min) for all Neonates in the control arm.(12-18 months)
- Number of Neonates administered Anti-epileptic drug (AED) in the investigation arm compared to Number of Neonates administered Anti-epileptic drug (AED) in the control arm.(12-18 months)
研究者
Professor Geraldine Boylan
Professor
University College Cork