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Automation Oxygen Flow Titration in Spontaneously Breathing Infants

NCT03614507 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-12-17

No results posted yet for this study

Summary

The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age.

FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

Conditions

  • Bronchiolitis

Interventions

DEVICE

FreeO2 (modèle FO2-220-00) automatic oxygen flow titration

Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate

DEVICE

FreeO2 (modèle FO2-220-00) manual oxygen flow titration

Manual oxygen flow titration performed by the healthcare provider in charge of the patient (nurse, physician). For this group, the FreeO2 device will only monitor and record SpO2 and heart rate.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Jean-Michel ROUE, Dr · CHU de Brest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2023-07-05
Completion
2023-07-05

Countries

  • France

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 NCT03614507 on ClinicalTrials.gov