Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population

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.

NCT Number	NCT06771206
Lead Sponsor	Owlet Baby Care, Inc. Collaborators: Children's of Alabama, University of Minnesota
Conditions	Pulse Oximeter Validation
Enrollment	20 participants
Start Date	2025-08-01
Primary Completion	2025-12 (estimated)
Study Completion	2026-02 (estimated)
Updated on ClinicalTrials.gov	2025-08-14