Pilot Study on the Use of a Wearable Remote Electroencephalography Device to Identify Neonates at Risk for Neonatal Seizures and Status Epilepticus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling
研究概览
简要总结
The purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.
详细描述
Our goals are to evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling. The current process for these patients would be transfer from Rochester Methodist Hospital to the St. Mary's level 3 NICU for EEG monitoring. Given that in case of neonatal encephalopathy, there is 6-hour window in which to make the critical decision of whether to initiate therapeutic hypothermia or not, rapid access to EEG data is crucial. We would like to perform a pilot study on use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 28 days old or less (postnatal age)
- •Neonatal encephalopathy as judged by clinical team or symptoms concerning for subtle seizures
- •Patient currently in level 1 newborn nursery or level 2 or 3 NICU
排除标准
- •Medical comorbidity which would result in prolonged need for sedation
- •Prolonged EEG monitoring is medically indicated
结局指标
主要结局
Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling
时间窗: Approximately 2 to 72 hours
Total number of neonates that Epilog device identifies as requiring formal EEG monitoring
Evaluate time to formal long-term EEG monitoring in neonates monitored with the Epilog device compared to a historical control cohort of neonates undergoing EEG evaluation.
时间窗: Approximately 2 to 72 hours
Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring.
次要结局
未报告次要终点
研究者
Anthony L. Fine, MD
Principal Investigator
Mayo Clinic