Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The aim of this clinical pilot study is to evaluate the validity, acceptability and usability of the newborn bed monitoring device among newborns, parents and healthcare professionals in hospital environment. The specific aims for the study are to:
- validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
- evaluate the feasibility on detecting awake, REM and non-REM sleep stages
- collect data on environmental factors from the infant sleep environment
- explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
- describe the key requirements for the bed monitoring device to be implemented in the newborn care path
The participating newborns will be sleeping on the bed monitoring device for two hours and the measurements of the device will be compared with the reference device (golden standard). The acceptability and usability will be assessed by parents and healthcare professionals by fulfilling a questionnaire and participating in interviews.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for newborns:
- •received informed consent from both parents/guardians
- •newborn is treated in the Ward of families and newborns
- •newborn is having normal health status without ongoing additional treatments. No
排除标准
- •Inclusion criteria for parents:
- •being a parent of newborn participating in the study with bed monitoring device
- •being able to participate in Finnish. No exclusion criteria
- •Inclusion criteria for healthcare professionals:
- •being a healthcare professional working with newborns
- •being able to participate in Finnish. No exclusion criteria
研究组 & 干预措施
Parents
Parents of the newborns participating in the study.
Newborn
Newborn is sleeping in the bed monitoring device for two hours
Healthcare professionals
Healthcare professionals participating in newborn care.
结局指标
主要结局
Heart rate
时间窗: Two hours from the beginning of the data collection
次要结局
未报告次要终点
研究者
Anna Axelin
Professor
University of Turku