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

University Hospital Center (CHU)

Status: Unknown

Conditions: Bronchiolitis

Treatments: Device: nCPAP; Device: HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT02457013

9433

Details and patient eligibility

About

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

Enrollment: 142 estimated patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

HFNC treatment

Experimental group

Description:

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)

Treatment:

Device: HFNC

nCPAP treatment

Active Comparator group

Description:

nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours)

Treatment:

Device: nCPAP