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

Not Applicable

• Conditions: Bronchiolitis
• Interventions: Device: HFNC; Device: nCPAP

• Registration Number: NCT02457013
• Lead Sponsor: University Hospital, Montpellier

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-27
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-26
• Last Update Submitted: 2015-05-26
• Study First Posted: 2015-05-29
• Last Update Posted: 2015-05-29
• Primary Completion: 2016-04
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• age<6months
• bronchiolitis
• mWCAS > or=3
• hospitalisation in pediatric intensive care unit
• signed consent form (2 parents)

Exclusion Criteria

• Intubated patient
• Neurological or cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC treatment	HFNC	HFNC : High flow nasal canula 24hours Patients will be treated by a High flow nasal canula (HFNC: 2l/kg/min) for the initial management of their bronchiolitis (24 hours)
nCPAP treatment	nCPAP	nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours)

Primary Outcome Measures

Name	Time	Method
Proportion of failure	24 hours	Proportion of failure in both arms during the first 24 hours. 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 Outcome Measures

Name	Time	Method
number of participants with an aggravation of the clinical score for respiratory distress arms	12hours	comparison of the clinical score for respiratory distress (mWCAS) in both arms
Comparison of the Report Sp02/Fi02 in both arms	24 hours	Assessment of Report Sp02/Fi02in both arms
number of participants with skin lesions in both arms	24 hours	number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)
number of participants with an increase of the clinical score for respiratory distress arms	1 hour	Assessment of Report Sp02/Fi02in both arms
number of participants with Discomfort in both arms	24 hours	Assessment of the discomfort in both arms with the score of EDIN

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France