High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial

Conditions
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Bronchiolitis

Intervention / Treatment
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* Device: High-flow nasal canula oxygen therapy
* Device: Low-flow oxygen therapy with standard nasal canula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions ) aged 7 days- 6 months transcutaneous SpO2 in room air < 95% modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5 agreement of at least one of the parents or legal tutor for his child to participate in biomedical research affiliation to social security (beneficiary or entitled), except beneficiary of State medical help Exclusion Criteria: Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP) Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy Inclusion in other observational study.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow nasal canula oxygen therapy<br>High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher&Paykel (F&P), NZ) | Device: High-flow nasal canula oxygen therapy<br>* 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%.<br>* Other names: Optiflow;|
| Active Comparator: Low-flow oxygen therapy<br>Low-flow oxygen therapy with standard nasal canula | Device: Low-flow oxygen therapy with standard nasal canula<br>* flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).<br>* Other names: Low-flow oxygen therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, oxygen therapy, High flow nasal canula oxygen therapy, Bronchiolitis