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

Launched by ANNA AXELIN · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new bed monitoring device designed for newborns in hospitals. The goal is to see how well this device can track important information about babies, such as their heart rate, breathing, and movements while they sleep. The study will also look at how well the device can tell if a baby is awake or in different stages of sleep. Additionally, researchers want to find out how parents and healthcare professionals feel about using this device and what features are important for it to be useful in caring for newborns.

To participate in this study, newborns need to be healthy and stay in the newborn care area of the hospital, and parents must give their permission. Parents will be asked to fill out questionnaires and share their thoughts in interviews about how easy the device is to use. The newborns will be monitored while sleeping on the device for about two hours, and the results will be compared to a standard medical device to ensure accuracy. This trial is an important step in making sure the bed monitoring device is safe and effective for use in hospitals.

Gender

ALL

Eligibility criteria

• 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 exclusion criteria
• Inclusion criteria for healthcare professionals:
• • being a healthcare professional working with newborns
• • being able to participate in Finnish. No exclusion criteria