ValidationNCT06679127
Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
An observational study of Validation, run by Anna Axelin at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Validation
- How many people
- 75 participants
- Where
- 1 siteFinland
- Study dates
- 12 May 2025to 18 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- being a parent of newborn participating in the study with bed monitoring device
- being able to participate in Finnish. No exclusion criteria
- being a healthcare professional working with newborns
- being able to participate in Finnish. No exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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:
- validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
- evaluate the feasibility on detecting awake, REM and non-REM sleep stages
- collect data on environmental factors from the infant sleep environment
- explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: Two hours from the beginning of the data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start12 May 2025
- Primary completion11 Jan 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Axelin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Axelin, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679127
- Sponsor's protocol ID
- VARHA/1994/13.02.01/2024
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Feasibility of Newborn Bed Monitoring Device - a Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT06679127
- Acronym / sponsor ID
- VARHA/1994/13.02.01/2024
- Conditions
- Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Anna AxelinUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 11 Jan 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- validate the following infant parameters collected with the bed monitoring device: heart rate, breathing rate, movements.
- evaluate the feasibility on detecting awake, REM and non-REM sleep stages
- collect data on environmental factors from the infant sleep environment
- explore how parents and healthcare professionals perceive the acceptability and usability of the bed monitoring device
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- being a parent of newborn participating in the study with bed monitoring device
- being able to participate in Finnish. No exclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate
Time frame: Two hours from the beginning of the data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation, run by Anna Axelin at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Two hours from the beginning of the data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.