High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

NCT03015051 | Terminated Phase 4

• 1 other identifier: High flow RCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 15

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

Keywords

Bronchiolitis; High flow nasal cannula; Oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Hours of oxygen therapy

  up to 5 days

Secondary Outcomes (4)

• 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

• Adverse events

  up to 15 days

Study Arms (2)

High flow

EXPERIMENTAL

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

Drug: Oxygen

Low flow

ACTIVE COMPARATOR

Low flow (max 3 L/min) oxygen therapy

Drug: Oxygen

Interventions

Oxygen DRUG

High flow; Low flow

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• chronic diseases or syndromes
• respiratory diseases (i.e. bronchopulmonary dysplasia)
• heart diseases
• preterm birth (before 36 weeks of gestational age)

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (15)

Ospedale Maggiore

Bologna, Emilia-Romagna, 40133, Italy

Location

Ospedale Morgagni-Pierantoni

Forlì, Emilia-Romagna, 47100, Italy

Location

Ospedale Ravenna AUSL Romagna

Ravenna, Emilia-Romagna, 48100, Italy

Location

Ospedale Santa Maria degli Angeli

Pordenone, Friuli Venezia Giulia, 33170, Italy

Location

Pediatric Emergency Department, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Ospedale Pediatrico IRCCS Bambino Gesú

Rome, Lazio, 00165, Italy

Location

Istituto G. Gaslini

Genoa, Liguria, 16120, Italy

Location

Fondazione MBBM c/o Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Location

Ospedale A. Cardarelli

Campobasso, Molise, 86170, Italy

Location

Ospedale Infantile Regina Margherita

Turin, Piedmont, 10100, Italy

Location

Ospedale Castelli

Verbania, Piedmont, 28992, Italy

Location

Ospedale Giovanni Paolo II

Olbia, Sardinia, 07026, Italy

Location

Ospedale Provinciale di Macerata

Macerata, The Marches, 62100, Italy

Location

Ospedale Principe di Piemonte Area Vasta 2

Senigallia, The Marches, 60019, Italy

Location

Azienda Ospedaliera di Padova

Padua, Veneto, 35100, Italy

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Egidio Barbi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Stefania Norbedo, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Epidemiology and Public Health Research Unit

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: January 9, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

IT (15)