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

March 13, 2024 updated by: Colm Travers, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Infants admitted to the neonatal intensive care unit.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bradycardia episodes
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).
48 hours
Hypoxemia episodes
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).
48 hours
Diagnostic accuracy
Time Frame: 48 hours
The false alarm rate and other key measures of diagnostic accuracy.
48 hours
Limits of agreement
Time Frame: 48 hours
The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Owlet Baby Care, Inc.

Investigators

  • Principal Investigator: Colm P Travers, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2023

Primary Completion (Actual)

July 29, 2023

Study Completion (Actual)

July 29, 2023

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300010237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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