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| Name | Class |
|---|---|
| Owlet Baby Care, Inc. | INDUSTRY |
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This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.
We will attach an Owlet monitor to infants for a 48-hour period. We will prospectively collect data from this device to determine the accuracy of bradycardia and hypoxemia detection compared with hospital monitors. In addition, we will collect simultaneous high-resolution real time cardiorespiratory data from Philips MP70 patient monitors at the University of Alabama at Birmingham.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Owlet OSS 3.0 | Device | The Owlet OSS 3.0 is a non-invasive monitoring device. The Sock secures the Sensor to the baby's foot. The Sensor measures the baby's SpO2, heart rate, and movement, and transmits the baby's readings to the Base Station. The Base Station records and monitors the baby's readings and can indicate prompts as needed based on the data sent from the Sensor. |
| Measure | Description | Time Frame |
|---|---|---|
| Bradycardia and/or hypoxemia | The diagnostic accuracy of the Owlet OSS 3.0 monitor for detection of bradycardia <50/min and/or hypoxemia with SpO2 <80% episodes for ≥3 seconds during a 48-hour period. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bradycardia episodes | The diagnostic accuracy of the Owlet OSS 3.0 monitor for episodes of bradycardia using alternative definitions of depth and duration (<50/min; < 80/min; < 100/min; lasting ≥ 10 seconds; lasting ≥ 20 seconds). | 48 hours |
| Hypoxemia episodes |
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Inclusion Criteria:
Exclusion Criteria:
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Infants admitted to the neonatal intensive care unit.
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| Name | Affiliation | Role |
|---|---|---|
| Colm P Travers, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40355254 | Derived | Travers CP, Nakhmani A, Armstead KM, Benz RL, Foshee KM, Carlo WA. Diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events. Arch Dis Child Fetal Neonatal Ed. 2025 Dec 15;111(1):F13-F19. doi: 10.1136/archdischild-2025-328540. |
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The diagnostic accuracy of episodes of intermittent hypoxemia of different severity and duration (<80%; <85%; lasting ≥ 10 seconds; lasting ≥ 20 seconds). |
| 48 hours |
| Diagnostic accuracy | The false alarm rate and other key measures of diagnostic accuracy. | 48 hours |
| Limits of agreement | The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors. | 48 hours |