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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.
Design: non-inferiority study, 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: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" 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 (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
Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
Study Schedule: October 2014-April 2016
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNC treatment | Experimental | 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) |
|
| nCPAP treatment | Active Comparator | nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFNC | Device | Hygh flow nasal canula HFNC |
| |
| nCPAP |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe MILESI, Doctor | Contact | 0033467336609 | c-milesi@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier | Recruiting | Montpellier | 34395 | France |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Device |
nasal nCPAP |
|
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 |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |