Bradycardia Recognition and Detection in Young Infants Part-I

Completed

• Conditions: Hypoxemia of Newborn; Neonatal Bradycardia

• Registration Number: NCT05774470
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Study Start: 2023-04-22
• Primary Completion: 2023-07-29
• Study Completion: 2023-07-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bradycardia and/or hypoxemia	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Bradycardia episodes	48 hours	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).
Limits of agreement	48 hours	The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors.
Hypoxemia episodes	48 hours	The diagnostic accuracy of episodes of intermittent hypoxemia of different severity and duration (\<80%; \<85%; lasting ≥ 10 seconds; lasting ≥ 20 seconds).
Diagnostic accuracy	48 hours	The false alarm rate and other key measures of diagnostic accuracy.

Trial Locations

Locations (1)

UAB Hospital; 🇺🇸 Birmingham, Alabama, United States