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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis.
However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.
Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal canula oxygen therapy | Experimental | High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher&Paykel (F&P), NZ) |
|
| Low-flow oxygen therapy | Active Comparator | Low-flow oxygen therapy with standard nasal canula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal canula oxygen therapy | Device | High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 > 94%. |
| Measure | Description | Time Frame |
|---|---|---|
| patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days | Treatment failure is defined if one or more following criteria are met: refractory apnea (> 3/h), oxygen requirement in HFN therapy arm exceeds fraction of inspired oxygen (FiO2) ≥ 40 % or oxygen requirement in standard nasal oxygen therapy arm exceeds >2l/min to maintain oxygen saturation (SpO2) ≥94 %), m-WCAS score increased compared to admission at H6 and/or > 5 , PaCO2 (H6 ) increased compared to admission and > 60-70 mmHg. | Up to an average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Transfer to pediatrics intensive care unit (PICU) | Numbers of infants transferred to PICU in each arm | at the end of the follow up (an average of 7 days) |
| Length of stay in paediatric general ward unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe DURAND, MD | AP-HP, Bicêtre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Bicêtre Hospital | Le Kremlin-Bicêtre | 94270 | 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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|
| Low-flow oxygen therapy with standard nasal canula | Device | flow adjusted to SpO2 > 94% (up to a maximum of 2l/min). |
|
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number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
| at the end of the follow up (an average of 7 days) |
| Oxgen-support free days | number of oxygen support free days | at the end of the follow up (an average of 7 days) |
| Artificial nutritional-support free days | number of artificial nutritional-support free days (enteral feeding or intravenous line) | at the end of the follow up (an average of 7 days) |
| Assessment of short term respiratory status | Sequential assessment of short term (H1, 6, 12, 24) respiratory status including respiratory rate, heart-rate, SpO2, m-WCAS score, transcutaneous carbon dioxide partial pressure (tcPaCO2). | at the end of the follow up (an average of 7 days) |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |