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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment by 2l/min/kg in HFNC | Active Comparator | 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 by 3l/min/kg in HFNC | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) | Device |
| ||
| treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of failure in both arms | 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. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Montpellier | Montpellier | 34285 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38197495 | Result | Milesi C, Nogue E, Baleine J, Moulis L, Pouyau R, Gavotto A, Brossier D, Mortamet G, Cambonie G; GFRUP Respiratory Study Group. ROX (Respiratory rate-OXygenation) index to predict early response to high-flow nasal cannula therapy in infants with viral bronchiolitis. Pediatr Pulmonol. 2024 Apr;59(4):982-990. doi: 10.1002/ppul.26860. Epub 2024 Jan 10. | |
| 30343318 |
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All data will be centralized at the sponsor office for the final analysis
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| Device |
|
FiO2 required to achieve an oxygen saturation between 94 and 97% |
| up to 24 hours |
| number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS) | up to 24 hours |
| Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21. |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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