Bradycardia Recognition and Detection in Young Infants Part-I

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-22

Study Completion Date

2023-07-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neonatal Bradycardia Hypoxemia of Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No