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

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

Study Overview

• Status: Unknown
• Conditions: Bronchiolitis
• Intervention / Treatment: Device: HFNC; Device: nCPAP

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34395
    • Recruiting
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFNC treatment; 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)	Device: HFNC; Hygh flow nasal canula HFNC
Active Comparator: nCPAP treatment; nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours)	Device: nCPAP; nasal nCPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of failure	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.	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 9433