Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Owlet Baby Care, Inc.
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Pulse oximetry Accuracy - Root Mean Square
Study Overview
Brief 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.
Detailed Description
This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate population up to 44 weeks corrected gestational age using convenience sampling of arterial blood gas samples as a part of routine clinical monitoring.
The Owlet OSS 3.0 Sensor is the component of the Owlet Dream Sock (DEN220091) and BabySat (K222597), both Food and Drug Administration (FDA) cleared pulse oximeters for infants 1-18 months in 2023. This component performs the signal acquisition and analysis to estimate pulse rate and SpO2 readings.
The study will enroll between 20-100 neonates weighing a minimum of 1500g in the hospital setting with available arterial line access and arterial blood gas samples being performed as part of planned patient management. No additional blood gas samples will be taken beyond clinical care indications.
The primary outcome of the study is the accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Secondary outcomes will include:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 0 Days to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Owlet Arm
All study participants meeting inclusion criteria with no stated exclusions will wear the Owlet OSS 3.0 Sensor during the study intervention. The Owlet OSS 3.0 Sensor may be placed continuously on a study subject for up to 48 hours with rotation to the opposite foot every 8 hours per device labeling to enable noninvasive data collection during the subject's standard of care blood draws. The Owlet base station will be activated in order to transmit readings but will not provide any external alarms or live displays during the monitoring period. No display of readings from the assigned Owlet device will be made available to the participant or the investigators during the time of data acquisition.
Intervention: Owlet pulse oximeter neonatal accuracy validation (Device)
Outcomes
Primary Outcomes
Pulse oximetry Accuracy - Root Mean Square
Time Frame: 48 hours
Accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Secondary Outcomes
- Pulse oximetry Accuracy - Bias(48 hours)
- Pulse oximetry Accuracy - Precision(48 hours)