High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis
- Registration Number
- NCT03015051
- Lead Sponsor
- IRCCS Burlo Garofolo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
- 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
- chronic diseases or syndromes
- respiratory diseases (i.e. bronchopulmonary dysplasia)
- heart diseases
- preterm birth (before 36 weeks of gestational age)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low flow Oxygen Low flow (max 3 L/min) oxygen therapy High flow Oxygen High flow (2 L/kg/min) nasal cannula oxygen therapy
- Primary Outcome Measures
Name Time Method Hours of oxygen therapy up to 5 days
- Secondary Outcome Measures
Name Time Method 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 up to 5 days Number of days
Adverse events up to 15 days Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated
Trial Locations
- Locations (15)
Ospedale A. Cardarelli
🇮🇹Campobasso, Molise, Italy
Ospedale Maggiore
🇮🇹Bologna, Emilia Romagna, Italy
Ospedale Morgagni-Pierantoni
🇮🇹Forlì, Emilia Romagna, Italy
Ospedale Pediatrico IRCCS Bambino Gesú
🇮🇹Rome, Lazio, Italy
Ospedale Santa Maria degli Angeli
🇮🇹Pordenone, Friuli Venezia Giulia, Italy
Pediatric Emergency Department, IRCCS Burlo Garofolo
🇮🇹Trieste, Friuli Venezia Giulia, Italy
Fondazione MBBM c/o Ospedale San Gerardo
🇮🇹Monza, Lombardia, Italy
Ospedale Provinciale di Macerata
🇮🇹Macerata, Marche, Italy
Ospedale Castelli
🇮🇹Verbania, Piemonte, Italy
Ospedale Infantile Regina Margherita
🇮🇹Torino, Piemonte, Italy
Ospedale Giovanni Paolo II
🇮🇹Olbia, Sardegna, Italy
Ospedale Ravenna AUSL Romagna
🇮🇹Ravenna, Emilia Romagna, Italy
Istituto G. Gaslini
🇮🇹Genova, Liguria, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Veneto, Italy
Ospedale Principe di Piemonte Area Vasta 2
🇮🇹Senigallia, Marche, Italy