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High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Oxygen
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, High flow nasal cannula, Oxygen therapy

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ospedale Maggiore
  • Ospedale Morgagni-Pierantoni
  • Ospedale Ravenna AUSL Romagna
  • Ospedale Santa Maria degli Angeli
  • Pediatric Emergency Department, IRCCS Burlo Garofolo
  • Ospedale Pediatrico IRCCS Bambino Gesú
  • Istituto G. Gaslini
  • Fondazione MBBM c/o Ospedale San Gerardo
  • Ospedale Provinciale di Macerata
  • Ospedale Principe di Piemonte Area Vasta 2
  • Ospedale A. Cardarelli
  • Ospedale Infantile Regina Margherita
  • Ospedale Castelli
  • Ospedale Giovanni Paolo II
  • Azienda Ospedaliera di Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow

Low flow

Arm Description

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

Low flow (max 3 L/min) oxygen therapy

Outcomes

Primary Outcome Measures

Hours of oxygen therapy

Secondary Outcome Measures

Number of subject admitted in intensive care unit
Number of patients needing intubation
Days of parenteral hydration or nasogastric enteral feeding
Number of days
Adverse events
Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated

Full Information

First Posted
November 24, 2016
Last Updated
September 2, 2020
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT03015051
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting subjects who meet the inclusion/exclusion criteria
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, High flow nasal cannula, Oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High flow
Arm Type
Experimental
Arm Description
High flow (2 L/kg/min) nasal cannula oxygen therapy
Arm Title
Low flow
Arm Type
Active Comparator
Arm Description
Low flow (max 3 L/min) oxygen therapy
Intervention Type
Drug
Intervention Name(s)
Oxygen
Primary Outcome Measure Information:
Title
Hours of oxygen therapy
Time Frame
up to 5 days
Secondary Outcome Measure Information:
Title
Number of subject admitted in intensive care unit
Time Frame
up to 5 days
Title
Number of patients needing intubation
Time Frame
up to 5 days
Title
Days of parenteral hydration or nasogastric enteral feeding
Description
Number of days
Time Frame
up to 5 days
Title
Adverse events
Description
Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated
Time Frame
up to 15 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidio Barbi, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefania Norbedo, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Maggiore
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Ospedale Morgagni-Pierantoni
City
Forlì
State/Province
Emilia Romagna
ZIP/Postal Code
47100
Country
Italy
Facility Name
Ospedale Ravenna AUSL Romagna
City
Ravenna
State/Province
Emilia Romagna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Ospedale Santa Maria degli Angeli
City
Pordenone
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
33170
Country
Italy
Facility Name
Pediatric Emergency Department, IRCCS Burlo Garofolo
City
Trieste
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34137
Country
Italy
Facility Name
Ospedale Pediatrico IRCCS Bambino Gesú
City
Rome
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Facility Name
Istituto G. Gaslini
City
Genova
State/Province
Liguria
ZIP/Postal Code
16120
Country
Italy
Facility Name
Fondazione MBBM c/o Ospedale San Gerardo
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Ospedale Provinciale di Macerata
City
Macerata
State/Province
Marche
ZIP/Postal Code
62100
Country
Italy
Facility Name
Ospedale Principe di Piemonte Area Vasta 2
City
Senigallia
State/Province
Marche
ZIP/Postal Code
60019
Country
Italy
Facility Name
Ospedale A. Cardarelli
City
Campobasso
State/Province
Molise
ZIP/Postal Code
86170
Country
Italy
Facility Name
Ospedale Infantile Regina Margherita
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10100
Country
Italy
Facility Name
Ospedale Castelli
City
Verbania
State/Province
Piemonte
ZIP/Postal Code
28992
Country
Italy
Facility Name
Ospedale Giovanni Paolo II
City
Olbia
State/Province
Sardegna
ZIP/Postal Code
07026
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

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