Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- Electrocardiography (ECG) Accuracy
研究概览
简要总结
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Measurements obtained from the wireless sensor system will be compared with standard-of-care monitoring. The study will also assess skin tolerability, signal quality, and parent and healthcare provider perceptions of the device.
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
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
排除标准
- •Infants with skin abnormality would potentially increase the risk of injury.
- •Family experiencing too much stress as determined by an attending physician or bedside care team, to not be approached for recruitment.
- •Infants born at <35 weeks gestational age.
结局指标
主要结局
Electrocardiography (ECG) Accuracy
时间窗: During two 15-minute monitoring periods within the first 90 minutes after birth
Agreement between ECG measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Skin Temperature Accuracy
时间窗: During two 15-minute monitoring periods within the first 90 minutes after birth.
Agreement between skin temperature measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
Oxygen Saturation (SpO₂) Accuracy
时间窗: During two 15-minute monitoring periods within the first 90 minutes after birth.
Agreement between oxygen saturation (SpO₂) measurements obtained using the Wireless MicroPremVitals Button Sensor System and the standard-of-care Dräger Infinity M540 monitor.
次要结局
- Heart Rate Accuracy(During two 15-minute monitoring periods within the first 90 minutes after birth.)
- Heart Rate Variability (HRV)(During two 15-minute monitoring periods within the first 90 minutes after birth.)
研究者
Guilherme Sant'Anna, MD
Neonatologist
McGill University Health Centre/Research Institute of the McGill University Health Centre