A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Seizure detection
研究概览
简要总结
For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.
详细描述
Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring.
EES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm.
Specific Aims:
- To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.)
- To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized neonates who already require continuous EEG recording for clinical care
- •Parents signed informed consent
- •CGA 44 weeks or less
排除标准
- •Patient is moribund
结局指标
主要结局
Seizure detection
时间窗: 24 hours
Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.
次要结局
- EEG characterization(24 hours)
- Skin integrity from standard EEG vs study electrodes(24 hours)
- Hair removal from standard EEG vs study electrodes(24 hours)
研究者
M J Harbert
Director of Neonatal Neurology
Sharp HealthCare