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

NCT06679127 | Completed

• 1 other identifier: VARHA/1994/13.02.01/2024
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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. 1.validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
2. 2.evaluate the feasibility on detecting awake, REM and non-REM sleep stages
3. 3.collect data on environmental factors from the infant sleep environment
4. 4.explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
5. 5.describe the key requirements for the bed monitoring device to be implemented in the newborn care path

Conditions

Validation

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Two hours from the beginning of the data collection

Study Arms (3)

Newborn

Newborn is sleeping in the bed monitoring device for two hours

Parents

Parents of the newborns participating in the study.

Healthcare professionals

Healthcare professionals participating in newborn care.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All parents will be informed about the study when moving from labour ward to postnatal ward. Newborns participating in the study will be approximately 1-3 days old. Parents of the participating newborns will be informed about the study and invited to participate to the study part for parents. All healthcare professionals working in the study unit during the newborn data collection are able to participate in the study part for healthcare professionals.

You may qualify if:

• received informed consent from both parents/guardians
• newborn is treated in the Ward of families and newborns

You may not qualify if:

• being a parent of newborn participating in the study with bed monitoring device
• being a healthcare professional working with newborns

Sponsors & Collaborators

• Anna Axelin: lead

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: May 12, 2025
• Primary Completion: January 11, 2026
• Study Completion: March 18, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FI (1)