Bronchiolitis Clinical Trial
Official title:
Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
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.
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