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

RecruitingNAAges 0 Days - 28 DaysAllOwlet Baby Care, Inc.
NCT06771206 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Owlet pulse oximeter neonatal accuracy validation
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Where

2 sites
University of Alabama Birmingham - Children's of Alabama
Birmingham, United States
University of Minnesota Medical Center
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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