Evaluation of a Smart Sock for Heart Rate Monitoring in Hospitalized Newborn Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Agreement between heart rate measurements obtained from the smart sock and the standard patient monitor
研究概览
简要总结
The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease. The study aims to determine whether the smart sock provides heart rate information comparable to that obtained from the standard patient monitor used in routine neonatal care.
The main questions this study aims to answer are:
- Does the smart sock provide heart rate measurements comparable to those obtained from the standard patient monitor?
- Does the smart sock provide comparable information on clinically relevant rhythm abnormalities?
- How do parents and healthcare professionals perceive the usability and safety of the smart sock? Participants will wear the smart sock while undergoing routine monitoring on the neonatal ward. Heart rate and rhythm data from the smart sock will be compared with data from the standard patient monitor. Parents and healthcare professionals will provide feedback on the usability and perceived safety of the device.
详细描述
Commercially available wearable monitoring devices for infants are increasingly used, but evidence on their performance in hospitalized newborns is limited. This study evaluates the accuracy and usability of the Owlet Dream Sock™ in hospitalized newborn infants. Heart rate and rhythm data obtained from the smart sock will be compared with data from the standard patient monitor used in routine neonatal care. In addition, parents and healthcare professionals will evaluate the usability and perceived safety 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
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospitalized newborn infant
- •Age <28 days
- •Gestational age ≥35+0 weeks
- •Birth weight ≥2 kg
- •Parental informed consent
排除标准
- •Known congenital heart disease
- •Hospital-acquired infection
- •Skin infection
- •Lack of parental consent
结局指标
主要结局
Agreement between heart rate measurements obtained from the smart sock and the standard patient monitor
时间窗: From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period
Heart rate data obtained from the smart sock will be compared with simultaneous heart rate data obtained from the standard patient monitor used in routine neonatal care.
次要结局
- Agreement in detection of rhythm abnormalities between the smart sock and the standard patient monitor(From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period)
- Parent- and healthcare professional-reported usability of the smart sock(Immediately after completion of the 12-16-hour smart sock monitoring period)