An observational study in Healthy and Newborn Infant, sponsored by Tampere University Hospital. Enrolling by invitation at 1 site in Finland. Open to participants aged 0 Days to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Tampere University Hospital · Observational
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:
Commercially available wearable monitoring devices for infants are increasingly used, but evidence on their performance in hospitalized newborns is limited. This study evaluates the accuracy and usability of the Owlet Dream Sock™ in hospitalized newborn infants. Heart rate and rhythm data obtained from the smart sock will be compared with data from the standard patient monitor used in routine neonatal care. In addition, parents and healthcare professionals will evaluate the usability and perceived safety of the device.
Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalized full-term and late preterm newborn infants receiving care in the neonatal intensive care unit and observation unit at Tampere University Hospital, Finland.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 period
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 period
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 period
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: start Sep 2026 → Aug 2026 and primary completion Jan 2027 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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