Bronchiolitis
Conditions
Keywords
Bronchiolitis, High flow nasal canula
Brief summary
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.
Interventions
DEVICEtreatment by 2l/min/kg in High Flow Nasal cannula (HFNC)
DEVICEtreatment by 3l/min/kg in High Flow Nasal cannula (HFNC)
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 6 Months
Healthy volunteers
No
Inclusion criteria
* age \< 6 months * bronchiolitis * mWCAS \> or =3 * hospitalisation: PICU * signed consent form by parents
Exclusion criteria
* Intubated patient * Neurological or cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of failure in both arms | up to 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| assessment of heart rate in both arm | up to 24 hours | — |
| Assessment of the discomfort in both arms with the score of EDIN | up to 24 hours | — |
| assessment of the fraction of inspired oxygen (FiO2) in both arms | up to 24 hours | FiO2 required to achieve an oxygen saturation between 94 and 97% |
| number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS) | up to 24 hours | — |
Countries
France
Outcome results
None listed