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Completed
NCT05635513
Owlet Smart Sock 3 Accuracy on Infants
Conditions: Hypoxia Neonatal
Sex: All
Enrollment: 28
Sponsor: Owlet Baby Care, Inc.
Location: United States
Summary
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously.
The monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the Owlet Smart Sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.
Eligibility Criteria
Inclusion Criteria:Infant who weigh between 1.7kg and 2.3kgInfant who is admitted to U of U NICUExclusion Criteria:Infant who has injuries, deformities, abnormalities, or intravenous catheter in the extremities that may prevent proper application of deviceInfant who has unstable vital signs or clinical conditionNo parental consentInability to achieve adequate fit with the OSS3
Source: ClinicalTrials.gov (NCT05635513). StuddyBuddy aggregates publicly available trial information.