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Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
Sponsor: Owlet Baby Care, Inc.
Summary
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date. The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.
Key Details
Gender
All
Age Range
0 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-08-01
Completion Date
2026-02
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Owlet pulse oximeter neonatal accuracy validation
This study specifically evaluates the Owlet pulse oximetry sensor, which is specifically designed and FDA cleared for for infants, and whose accuracy is specifically being validated in the neonate population.
Locations (2)
University of Alabama Birmingham - Children's of Alabama
Birmingham, Alabama, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States