Bradycardia Recognition and Detection in Young Infants Part-I

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.

Full Title of Study: “Bradycardia Recognition and Detection in Young Infants Using the Owlet OSS 3.0 Monitor (Brady-I Study)”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: March 31, 2024

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.

Interventions

• 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.

Clinical Trial Outcome Measures

Primary Measures

• Bradycardia and/or hypoxemia
  • Time Frame: 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

• Infants must meet all of the following criteria to be eligible: Off ventilatory support/NCPAP/HFNC and phototherapy for > 48 hours prior to study entry Less than one-year corrected age Current weight >1500 grams Parents/legal guardians have provided consent for enrollment Exclusion Criteria:

• Infants will be excluded from this study if they have any of the following: a major malformation, a neuromuscular condition that affects respiration or causes apnea, active skin breakdown or skin infection, or terminal illness or decision to withhold or limit support. We will exclude data from infants who develop shock/sepsis or require ventilatory support or during phototherapy during the study period.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 365 Days

Investigator Details

• Lead Sponsor
  • University of Alabama at Birmingham
• Collaborator
  • Owlet Baby Care, Inc.
• Provider of Information About this Clinical Study
  • Principal Investigator: Colm Travers, Dr. Colm Travers MD – University of Alabama at Birmingham
• Overall Official(s)
  • Colm P Travers, MD, Principal Investigator, University of Alabama at Birmingham
• Overall Contact(s)
  • Kimberly A Armstead, BS, 205-934-0095, karmstead@uabmc.edu