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Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants

NCT02824744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-05-30

No results posted yet for this study

Summary

The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.

Design: Prospective, controlled, randomized, multi-center.

Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS \>3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups:HFNC "2l/min/kg" or HFNC "3l/min/kg" during 24 hours.

Conditions of measurements:

Primary endpoint: Proportion of failure in both arms during the first 24 hours.

Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2

Statistic: Intention to treat Analysis.

Expected number of patients: 135 per arm: 270 children.

Conditions

  • Bronchiolitis

Interventions

DEVICE

treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)

DEVICE

treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-02
Primary Completion
2017-03-17
Completion
2018-03-31

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 NCT02824744 on ClinicalTrials.gov