Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room
2026年7月28日 更新者：Guilherme Sant'Anna, MD、McGill University Health Centre/Research Institute of the McGill University Health Centre
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.
研究概览
研究类型
观察性的
注册 (估计的)
5
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Alyssa Maximov, BSc.
- 电话号码：78229 5149341934
- 邮箱：alyssa.maximov@muhc.mcgill.ca
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Healthy newborn infants in the delivery room at the study site who are eligible for routine delivery room monitoring and whose parent(s) or legal guardian provide informed consent for study participation.
描述
Inclusion Criteria:
- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Newborn Infants
Healthy newborn infants enrolled in the study who will undergo simultaneous monitoring with the Wireless MicroPremVitals Button Sensor System and standard-of-care monitoring in the delivery room to evaluate the accuracy, safety, and feasibility of the wireless monitoring system.
|
A wireless wearable sensor system applied to newborn infants in the delivery room to continuously measure electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature.
Measurements will be compared with standard-of-care monitoring for validation purposes only and will not be used for clinical decision-making.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electrocardiography (ECG) Accuracy
大体时间：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.
|
During two 15-minute monitoring periods within the first 90 minutes after birth
|
|
Skin Temperature Accuracy
大体时间：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.
|
During two 15-minute monitoring periods within the first 90 minutes after birth.
|
|
Oxygen Saturation (SpO₂) Accuracy
大体时间：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.
|
During two 15-minute monitoring periods within the first 90 minutes after birth.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Heart Rate Accuracy
大体时间：During two 15-minute monitoring periods within the first 90 minutes after birth.
|
Heart rate will be calculated offline from raw optical and motion data collected by the Wireless MicroPremVitals Button Sensor System.
Agreement between calculated heart rate and the standard-of-care Dräger Infinity M540 monitor will be evaluated.
|
During two 15-minute monitoring periods within the first 90 minutes after birth.
|
|
Heart Rate Variability (HRV)
大体时间：During two 15-minute monitoring periods within the first 90 minutes after birth.
|
Heart rate variability will be calculated offline from raw optical and motion data collected by the Wireless MicroPremVitals Button Sensor System.
Derived HRV measurements will be compared with HRV derived from the standard-of-care Dräger Infinity M540 monitor.
|
During two 15-minute monitoring periods within the first 90 minutes after birth.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Guilherme Sant'Anna, MD, PhD、RI-MUHC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2026年7月28日
首先提交符合 QC 标准的
2026年7月28日
首次发布 (实际的)
2026年7月31日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.