High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

IRCCS Burlo Garofolo

Status and phase: Terminated; Phase 4

Conditions: Bronchiolitis

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT03015051

High flow RCT

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

High flow

Experimental group

Description:

High flow (2 L/kg/min) nasal cannula oxygen therapy

Treatment:

Drug: Oxygen

Low flow

Active Comparator group

Description:

Low flow (max 3 L/min) oxygen therapy

Treatment:

Drug: Oxygen