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OpenTrials
Completed

NCT Number: NCT06679127

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

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.

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Key information

Conditions

Validation

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku University Hospital

Turku, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Heart rate

    Time frame: Two hours from the beginning of the data collection

Sponsors and collaborators

Lead sponsor

Anna Axelin

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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