Continuous Vital Sign Monitoring in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
研究概览
简要总结
This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.
详细描述
This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice & its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .
Once alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.
Nurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.
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 Hours 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy infants <12 hours of age
- •Expected to be admitted to the Well Baby Nursery
- •36 or more weeks gestation at birth
- •Mother at least 18 years of age
排除标准
- •Infants requiring any non-routine medical care or observation
- •Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
- •Multiple birth
结局指标
主要结局
Assessment of feasibility by questionnaires to nurses and mothers using the using the Technology Acceptance Model (TAM).
时间窗: Up to 3 days
TAM questionnaires will be distributed to the nurse taking care of each subject at the time of discharge of the infant. The questionnaire will include informed consent by the nurse for participation in the research. A similar questionnaire will also be distributed to the mother just prior to discharge.
次要结局
- Accuracy assessed by comparison to conventional vital sign measurements within a 2-minute window(Up to 3 days)
- Clinical Utility as measured by false alerts(Up to 3 days)
研究者
Barry Weinberger
Principal Investigator
Northwell Health