Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
Owlet Baby Care, Inc.
20 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Less than or equal to 44 weeks corrected gestational age
- Weight equal or greater than 1500g
- Subjects with standard of care (SOC) arterial blood sampling line already in place at time of enrollment, with anticipated arterial blood gas measurements as part of their plan of care
Exclusion Criteria6
- Subjects with underdeveloped skin as assessed by a study investigator and/or reported by the clinical care team
- Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements
- Potential subjects on extracorporeal membrane oxygenation (ECMO) or other mechanical circulatory support
- Arterial line is placed in a preductal position with the potential of pulmonary to systemic shunting
- Subjects undergoing cooling protocol/therapeutic hypothermia
- Subjects who are deemed too clinically unstable by the Principal Investigator (PI), sub-investigator and/or clinical care team to participate in the study.
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06771206