Bradycardia Recognition and Detection in Young Infants Part-I

Completed

Conditions studied: Neonatal Bradycardia, Hypoxemia of Newborn

In brief

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.

Key facts

Study ID

NCT05774470

Run by

University of Alabama at Birmingham

People needed

70

Starts

2023-04-22

Expected to finish

2023-07-29

Last updated by the study team

2024-03-15

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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