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Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants

NCT02457013 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2015-05-29

No results posted yet for this study

Summary

1. The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
2. Design: non-inferiority study, prospective, controlled, randomized, multi-center.
3. 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: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
4. 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 (fraction of inspired oxygen

) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2
5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
6. Study Schedule: October 2014-April 2016

Conditions

  • Bronchiolitis

Interventions

DEVICE

HFNC

Hygh flow nasal canula HFNC

DEVICE

nCPAP

nasal nCPAP

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-04-30
Completion
2016-11-30

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 NCT02457013 on ClinicalTrials.gov