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Bradycardia Recognition and Detection in Young Infants Part-I

NCT05774470 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Neonatal Bradycardia
  • Hypoxemia of Newborn

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.

Sponsors & Collaborators

  • Owlet Baby Care, Inc.

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Colm P Travers, MD · University of Alabama at Birmingham

Eligibility

Min Age
1 Day
Max Age
365 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-22
Primary Completion
2023-07-29
Completion
2023-07-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774470 on ClinicalTrials.gov