Bradycardia Recognition and Detection in Young Infants Part-I

University of Alabama at Birmingham70 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neonatal Bradycardia Hypoxemia of Newborn

Interventions

Owlet OSS 3.0DEVICE

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.

Eligibility

Sex: ALLMin age: 1 DayMax age: 365 Days

Medical Language ↔ Plain English

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.

Locations (1)

UAB Hospital

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 hours

Secondary Outcomes

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).

Time frame: 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).

Time frame: 48 hours

Diagnostic accuracy

The false alarm rate and other key measures of diagnostic accuracy.

Time frame: 48 hours

Limits of agreement

The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors.

Time frame: 48 hours

Data from ClinicalTrials.gov

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