Smart Sock Heart Rate Monitoring in Hospitalized Newborns
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorTampere University Hospital
About this trial
The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease. The study aims to determine whether the smart sock provides heart rate information comparable to that obtained from the standard patient monitor used in routine neonatal care.
The main questions this study aims to answer are:
* Does the smart sock provide heart rate measurements comparable to those obtained from the standard patient monitor? * Does the smart sock provide comparable information on clinically relevant rhythm abnormalities? * How do parents and healthcare professionals perceive the usability and safety of the smart sock? Participants will wear the smart sock while undergoing routine monitoring on the neonatal ward. Heart rate and rhythm data from the smart sock will be compared with data from the standard patient monitor. Parents and healthcare professionals will provide feedback on the usability and perceived safety of the device.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Hospitalized newborn infant
Age <28 days
Gestational age ≥35+0 weeks
Birth weight ≥2 kg
Disqualifiers
Known congenital heart disease
Hospital-acquired infection
Skin infection
Lack of parental consent
Trial population
Hospitalized full-term and late preterm newborn infants receiving care in the neonatal intensive care unit and observation unit at Tampere University Hospital, Finland.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Agreement between heart rate measurements obtained from the smart sock and the standard patient monitor
Heart rate data obtained from the smart sock will be compared with simultaneous heart rate data obtained from the standard patient monitor used in routine neonatal care.
Time frame
From initiation of smart sock monitoring through completion of the 12-16-hour monitoring periodSecondary outcomes
1
Agreement in detection of rhythm abnormalities between the smart sock and the standard patient monitor
Rhythm abnormalities and rhythm-related alarms identified by the standard patient monitor will be reviewed and compared with data obtained from the smart sock to assess the ability of the smart sock to detect clinically significant rhythm abnormalities lasting \>3 minutes.
Time frame
From initiation of smart sock monitoring through completion of the 12-16-hour monitoring period2
Parent- and healthcare professional-reported usability of the smart sock
Usability of the smart sock as assessed by parents and healthcare professionals using a questionnaire.
Time frame
Immediately after completion of the 12-16-hour smart sock monitoring periodLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University Hospital
Lead sponsor
Owlet Baby Care, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: