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Smart Sock Heart Rate Monitoring in Hospitalized Newborns

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrolling by invitation only
    • Start date changed from estimate of Sep 30, 2026 to Aug 30, 2026
    • Study sites: 0 to 1
    • Primary completion date: Jan 2027 to Feb 2027
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07838402
Lead Sponsor Tampere University Hospital
Collaborators: Owlet Baby Care, Inc.
Conditions
(from sponsor)		 Healthy, Newborn Infant
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov