High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis

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.

Study Overview

• Status: Terminated
• Conditions: Bronchiolitis
• Intervention / Treatment: Drug: Oxygen

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Bologna, Emilia Romagna, Italy, 40133
      • Ospedale Maggiore
    • Forlì, Emilia Romagna, Italy, 47100
      • Ospedale Morgagni-Pierantoni
    • Ravenna, Emilia Romagna, Italy, 48100
      • Ospedale Ravenna AUSL Romagna
  • Friuli Venezia Giulia
    • Pordenone, Friuli Venezia Giulia, Italy, 33170
      • Ospedale Santa Maria degli Angeli
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • Pediatric Emergency Department, IRCCS Burlo Garofolo
  • Lazio
    • Rome, Lazio, Italy, 00165
      • Ospedale Pediatrico IRCCS Bambino Gesú
  • Liguria
    • Genova, Liguria, Italy, 16120
      • Istituto G. Gaslini
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • Fondazione MBBM c/o Ospedale San Gerardo
  • Marche
    • Macerata, Marche, Italy, 62100
      • Ospedale Provinciale di Macerata
    • Senigallia, Marche, Italy, 60019
      • Ospedale Principe di Piemonte Area Vasta 2
  • Molise
    • Campobasso, Molise, Italy, 86170
      • Ospedale A. cardarelli
  • Piemonte
    • Torino, Piemonte, Italy, 10100
      • Ospedale Infantile Regina Margherita
    • Verbania, Piemonte, Italy, 28992
      • Ospedale Castelli
  • Sardegna
    • Olbia, Sardegna, Italy, 07026
      • Ospedale Giovanni Paolo II
  • Veneto
    • Padova, Veneto, Italy, 35100
      • Azienda Ospedaliera di Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow; High flow (2 L/kg/min) nasal cannula oxygen therapy	Drug: Oxygen
Active Comparator: Low flow; Low flow (max 3 L/min) oxygen therapy	Drug: Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hours of oxygen therapy	up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Number of days	up to 5 days
Adverse events	Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated	up to 15 days

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Stefania Norbedo, MD, IRCCS Burlo Garofolo, Trieste, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Oxygen therapy; High flow nasal cannula; Bronchiolitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: High flow RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided