Clinical trial NCT03015051: High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis
Official title: Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bronchiolitis
Keywords: Bronchiolitis
High flow nasal cannula
Oxygen therapy
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Hours of oxygen therapy
timeFrame: up to 5 days
Secondary outcomes:
measure: Number of subject admitted in intensive care unit
timeFrame: up to 5 days
measure: Number of patients needing intubation
timeFrame: up to 5 days
measure: Days of parenteral hydration or nasogastric enteral feeding
timeFrame: up to 5 days
measure: Adverse events
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Ospedale Maggiore
state: Emilia Romagna
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
state: Emilia Romagna
city: Ravenna
country: Italy
facility: Ospedale Ravenna AUSL Romagna
state: Emilia Romagna
city: Pordenone
country: Italy
facility: Ospedale Santa Maria degli Angeli
state: Friuli Venezia Giulia
city: Trieste
country: Italy
facility: Pediatric Emergency Department, IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
city: Rome
country: Italy
facility: Ospedale Pediatrico IRCCS Bambino Gesú
state: Lazio
city: Genova
country: Italy
facility: Istituto G. Gaslini
state: Liguria
city: Monza
country: Italy
facility: Fondazione MBBM c/o Ospedale San Gerardo
state: Lombardia
city: Macerata
country: Italy
facility: Ospedale Provinciale di Macerata
state: Marche
city: Senigallia
country: Italy
facility: Ospedale Principe di Piemonte Area Vasta 2
state: Marche
city: Campobasso
country: Italy
facility: Ospedale A. Cardarelli
state: Molise
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita
state: Piemonte
city: Verbania
country: Italy
facility: Ospedale Castelli
state: Piemonte
city: Olbia
country: Italy
facility: Ospedale Giovanni Paolo II
state: Sardegna
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Egidio Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Stefania Norbedo, MD
role: STUDY_DIRECTOR
References: