Owlet OSS 3.0 oxygen sensor accuracy in newborns
Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
This study will test if the Owlet OSS 3.0 foot sensor gives accurate oxygen saturation (SpO2) readings for hospitalized newborns who already have arterial blood sampling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Owlet Baby Care, Inc. Industry-sponsored |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT06771206 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll 20–100 neonates up to 44 weeks corrected gestational age who weigh at least 1500 g and already have an arterial line in place for routine care. In this single-arm, prospective study the Owlet OSS 3.0 sensor will record SpO2 readings at the same time arterial blood gas samples (SaO2) are drawn, with no additional blood draws beyond clinical care. The primary outcome is root-mean-square accuracy (ARMS) of sensor SpO2 versus arterial SaO2, and secondary outcomes include bias and precision with stratification by factors such as skin tone. Data collection will occur at two hospital sites using convenience sampling of clinically indicated arterial blood gases.
Who should consider this trial
Good fit: Ideal candidates are hospitalized neonates up to 44 weeks corrected gestational age, weighing at least 1500 g, who already have an arterial line with planned arterial blood gas testing as part of care.
Not a fit: Babies without arterial access, weighing under 1500 g, on ECMO or therapeutic hypothermia, with preductal arterial lines, severe skin or limb abnormalities, or who are too clinically unstable are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If accurate, the Owlet sensor could provide reliable, less invasive oxygen monitoring for newborns and support safer bedside or home monitoring decisions.
How similar studies have performed: Pulse oximetry devices have been validated in older infants and other neonatal oximeters exist, and the Owlet components are FDA-cleared for older infants, but formal neonatal validation of this sensor is limited so the approach is partly established yet still novel for newborns.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama Birmingham - Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Gwenyth Fischer, M.D. — University of Minnesota Medical Center
- Study coordinator: Alisa L Niksch, M.D.
- Email: clinical@owletcare.com
- Phone: (844) 334-5330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.