NCT05774470

Bradycardia Recognition and Detection in Young Infants Part-I

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 365 Days
• Healthy volunteers: —

Summary

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

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.

Conditions

• Neonatal Bradycardia
• Hypoxemia of Newborn

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-22
• Primary completion: 2023-07-29
• Completion: 2023-07-29
• First posted: 2023-03-17
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study