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NCT05774470 · ClinicalTrials.gov registry record

Bradycardia Recognition and Detection in Young Infants Part-I

A clinical trial of Hypoxemia of Newborn and Neonatal Bradycardia, sponsored by University of Alabama at Birmingham.

Completed
Registry status
70
Enrollment target
1
Study location

NCT05774470: Completed study of Hypoxemia of Newborn and Neonatal Bradycardia, sponsored by University of Alabama at Birmingham.

NCT05774470 is a study of Hypoxemia of Newborn and Neonatal Bradycardia that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 70 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05774470, a study of Hypoxemia of Newborn and Neonatal Bradycardia, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
70 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Interventions

  • DEVICE Owlet OSS 3.0

Study Locations (1)

Alabama

  • UAB Hospital - Birmingham

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-04-22
Est. Completion 2023-07-29
University of Alabama at Birmingham

1,160 total trials

What the finished NCT05774470 record still lists

NCT05774470 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target.

The record links to 2 conditions, with Hypoxemia of Newborn appearing as the primary indexed condition, and to 1 intervention - of which Owlet OSS 3.0 is the first listed.

NCT05774470 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT05774470 about?

NCT05774470 is a clinical study titled "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.

What is the current status of trial NCT05774470?

This trial is currently completed. The enrollment target is 70 participants. The study started on 2023-04-22. Estimated completion is 2023-07-29.

What conditions does trial NCT05774470 study?

This clinical trial studies the following conditions: Hypoxemia of Newborn, Neonatal Bradycardia.

What interventions are being tested in trial NCT05774470?

The interventions under investigation include: Owlet OSS 3.0 (DEVICE).

Who is sponsoring clinical trial NCT05774470?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05774470 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05774470, the US trial registry maintained by the National Library of Medicine. NCT05774470 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.