High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

NCT ID: NCT03015051

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High flow

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

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: DRUG

Low flow

Low flow (max 3 L/min) oxygen therapy

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: DRUG

Interventions

Oxygen

Intervention Type: DRUG

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)

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Luca Ronfani

Head of Clinical Epidemiology and Public Health Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Egidio Barbi, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo, Trieste, Italy

Stefania Norbedo, MD

Role: STUDY_DIRECTOR

IRCCS Burlo Garofolo, Trieste, Italy

Locations

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

Ospedale Castelli

Verbania, Piedmont, Italy

Ospedale Giovanni Paolo II

Olbia, Sardinia, Italy

Ospedale Provinciale di Macerata

Macerata, The Marches, Italy

Ospedale Principe di Piemonte Area Vasta 2

Senigallia, The Marches, Italy

Azienda Ospedaliera di Padova

Padua, Veneto, Italy

Countries

Italy

Other Identifiers

High flow RCT

Identifier Type: -

Identifier Source: org_study_id