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NCT Number: NCT05774470

Bradycardia Recognition and Detection in Young Infants Part-I

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.

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Key information

Conditions

Neonatal Bradycardia Hypoxemia of Newborn

Age range

1 day–365 day

Sex eligibility

All sexes

Study type

Observational

Primary location

UAB Hospital

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Owlet OSS 3.0

Device

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.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. Diagnostic accuracy

    Time frame: 48 hours

    The false alarm rate and other key measures of diagnostic accuracy.

  4. Limits of agreement

    Time frame: 48 hours

    The limits of agreement of overall heart rate and oxygen saturation recordings compared with hospital monitors.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Owlet Baby Care, Inc.

Registry information

Official study title

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

Acronym: BRADY-I

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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