NCT06679127

Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Anna Axelin · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Validation

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-01-11
• Completion: 2026-03-18
• First posted: 2024-11-07
• Last updated: 2026-03-27

Locations

1 site across 1 country: Finland