Bradycardia Recognition and Detection in Young Infants Part-I

Neonatal Bradycardia Clinical Trial

— BRADY-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774470
• Other study ID #: 300010237
• Status: Completed
• Start date: April 22, 2023
• Est. completion date: July 29, 2023

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 29, 2023
• Est. primary completion date: July 29, 2023
• Gender: All
• Age group: 1 Day to 365 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Hypoxia
• Neonatal Bradycardia

Intervention

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.

Locations

Country	Name	City	State
United States	UAB Hospital	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Owlet Baby Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Diagnostic accuracy	The false alarm rate and other key measures of diagnostic accuracy.	48 hours
Secondary	Limits of agreement	The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors.	48 hours