Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants (TRAMONTANE2)

University Hospital Center (CHU)

Status: Completed

Conditions: Bronchiolitis

Treatments: Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC); Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02824744

9719

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age < 6 months
• bronchiolitis
• mWCAS > or =3
• hospitalisation: PICU
• signed consent form by 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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300 participants in 2 patient groups

treatment by 2l/min/kg in HFNC

Active Comparator group

Description:

treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old)

Treatment:

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

treatment by 3l/min/kg in HFNC

Experimental group

Description:

treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old)

Treatment:

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