Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
NCT ID: NCT06679127
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
315 participants
OBSERVATIONAL
2025-06-16
2026-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newborn
Newborn is sleeping in the bed monitoring device for two hours
No interventions assigned to this group
Parents
Parents of the newborns participating in the study.
No interventions assigned to this group
Healthcare professionals
Healthcare professionals participating in newborn care.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* newborn is treated in the Ward of families and newborns
* being a parent of newborn participating in the study with bed monitoring device
* being a healthcare professional working with newborns
ALL
Yes
Sponsors
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Anna Axelin
OTHER
Responsible Party
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Anna Axelin
Professor
Locations
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Turku University Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VARHA/1994/13.02.01/2024
Identifier Type: -
Identifier Source: org_study_id
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