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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Ospedale Maggiore
Bologna, Emilia-Romagna, Italy
Ospedale Morgagni-Pierantoni
Forlì, Emilia-Romagna, Italy
Ospedale Ravenna AUSL Romagna
Ravenna, Emilia-Romagna, Italy
Ospedale Santa Maria degli Angeli
Pordenone, Friuli Venezia Giulia, Italy
Pediatric Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy
Ospedale Pediatrico IRCCS Bambino Gesú
Rome, Lazio, Italy
Istituto G. Gaslini
Genoa, Liguria, Italy
Fondazione MBBM c/o Ospedale San Gerardo
Monza, Lombardy, Italy
Ospedale A. Cardarelli
Campobasso, Molise, Italy
Ospedale Infantile Regina Margherita
Turin, Piedmont, Italy
...and 5 more locations
Hours of oxygen therapy
Time frame: up to 5 days
Number of subject admitted in intensive care unit
Time frame: up to 5 days
Number of patients needing intubation
Time frame: up to 5 days
Days of parenteral hydration or nasogastric enteral feeding
Number of days
Time frame: up to 5 days
Adverse events
Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated
Time frame: up to 15 days
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