Bradycardia Recognition and Detection in Young Infants Part-I
BRADY-I
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedStudy Start
First participant enrolled
April 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2023
CompletedMarch 15, 2024
March 1, 2024
3 months
March 7, 2023
March 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Bradycardia episodes
48 hours
Hypoxemia episodes
48 hours
Diagnostic accuracy
48 hours
Limits of agreement
48 hours
Interventions
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.
Eligibility Criteria
Infants admitted to the neonatal intensive care unit.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Owlet Baby Care, Inc.collaborator
Study Sites (1)
UAB Hospital
Birmingham, Alabama, 35294, United States
Related Publications (1)
Travers CP, Nakhmani A, Armstead KM, Benz RL, Foshee KM, Carlo WA. Diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events. Arch Dis Child Fetal Neonatal Ed. 2025 Dec 15;111(1):F13-F19. doi: 10.1136/archdischild-2025-328540.
PMID: 40355254DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Colm P Travers, MD
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 17, 2023
Study Start
April 22, 2023
Primary Completion
July 29, 2023
Study Completion
July 29, 2023
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share