Bradycardia Recognition and Detection in Young Infants Part-I

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bradycardia Recognition and Detection in Young Infants Using the Owlet OSS 3.0 Monitor (Brady-I Study)

Conditions
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Neonatal Bradycardia, Hypoxemia of Newborn

Intervention / Treatment
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* Device: Owlet OSS 3.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Off ventilatory support/NCPAP/HFNC and phototherapy for > 48 hours Less than one-year corrected age Current weight >1500 grams Parents/legal guardians have provided consent for enrollment Exclusion Criteria: a major malformation a neuromuscular condition that affects respiration or causes apnea active skin breakdown or skin infection terminal illness or decision to withhold or limit support We will exclude data from infants who develop shock/sepsis or require ventilatory support or phototherapy during the study period.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 365 Days

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Owlet OSS 3.0|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |