Validation
Conditions
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.
Interventions
None listed
Sponsors
Anna Axelin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
Inclusion criteria for parents: * being a parent of newborn participating in the study with bed monitoring device * being able to participate in Finnish. No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate | Two hours from the beginning of the data collection |
Countries
Finland
Outcome results
None listed