Bradycardia Recognition and Detection in Young Infants Part-I (BRADY-I)

The University of Alabama at Birmingham

Status: Completed

Conditions: Hypoxemia of Newborn; Neonatal Bradycardia

Treatments: Device: Owlet OSS 3.0

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05774470

300010237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 1 to 365 days old

Volunteers: No Healthy Volunteers

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.