High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via head box. The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC. The aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.

Official Title
-----------------
Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of bronchiolitis age >28 days and <6 months Oxygen saturation (SaO2) <92% respiratory rate >60 breaths/min dyspnea with respiratory distress assessment instrument (RDAI) score ≥8 daily milk or food intake less than 2/3 than normally assumed Exclusion Criteria: chronic diseases or syndromes respiratory diseases (i.e. bronchopulmonary dysplasia) heart diseases preterm birth (before 36 weeks of gestational age)

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow<br>High flow (2 L/kg/min) nasal cannula oxygen therapy | Drug: Oxygen<br> <br> |
| Active Comparator: Low flow<br>Low flow (max 3 L/min) oxygen therapy | Drug: Oxygen<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours of oxygen therapy |  | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subject admitted in intensive care unit |  | up to 5 days | 
| Number of patients needing intubation |  | up to 5 days | 
| Days of parenteral hydration or nasogastric enteral feeding | Number of days | up to 5 days | 
| Adverse events | Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated | up to 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis, High flow nasal cannula, Oxygen therapy