Clinical trial NCT02457013: Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants
Official title: Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 142
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of failure
timeFrame: 24 hours
Secondary outcomes:
measure: number of participants with an aggravation of the clinical score for respiratory distress arms
timeFrame: 1hour
measure: number of participants with an aggravation of the clinical score for respiratory distress arms
timeFrame: 12hours
measure: number of participants with an increase of the clinical score for respiratory distress arms
timeFrame: 1 hour
measure: Comparison of the Report Sp02/Fi02 in both arms
timeFrame: 1 hour
measure: Comparison of the Report Sp02/Fi02 in both arms
timeFrame: 12 hours
measure: Comparison of the Report Sp02/Fi02 in both arms
timeFrame: 24 hours
measure: number of participants with skin lesions in both arms
timeFrame: 1 hour
measure: number of participants with skin lesions in both arms
timeFrame: 12 hours
measure: number of participants with skin lesions in both arms
timeFrame: 24 hours
measure: number of participants with Discomfort in both arms
timeFrame: 1 hour
measure: number of participants with Discomfort in both arms
timeFrame: 12 hours
measure: number of participants with Discomfort in both arms
timeFrame: 24 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References: