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

March 26, 2026 updated by: Anna Axelin

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: Two hours from the beginning of the data collection
Two hours from the beginning of the data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Axelin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Actual)

January 11, 2026

Study Completion (Actual)

March 18, 2026

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • VARHA/1994/13.02.01/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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