Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
- Conditions
- Validation
- Registration Number
- NCT06679127
- Lead Sponsor
- Anna Axelin
- Brief Summary
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:
1. validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
2. evaluate the feasibility on detecting awake, REM and non-REM sleep stages
3. collect data on environmental factors from the infant sleep environment
4. explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
5. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 315
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heart rate Two hours from the beginning of the data collection
- Secondary Outcome Measures
Name Time Method