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High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015051
Recruitment Status : Terminated (Difficulty in recruiting subjects who meet the inclusion/exclusion criteria)
First Posted : January 9, 2017
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Luca Ronfani, IRCCS Burlo Garofolo

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.


Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: Oxygen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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



Primary Outcome Measures :
  1. Hours of oxygen therapy [ Time Frame: up to 5 days ]

Secondary Outcome Measures :
  1. Number of subject admitted in intensive care unit [ Time Frame: up to 5 days ]
  2. Number of patients needing intubation [ Time Frame: up to 5 days ]
  3. Days of parenteral hydration or nasogastric enteral feeding [ Time Frame: up to 5 days ]
    Number of days

  4. Adverse events [ Time Frame: up to 15 days ]
    Number and type. Frequency of possible complication such as pneumothorax, pneumomediastinum or atelectasis will be evaluated



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015051


Locations
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Italy
Ospedale Maggiore
Bologna, Emilia Romagna, Italy, 40133
Ospedale Morgagni-Pierantoni
Forlì, Emilia Romagna, Italy, 47100
Ospedale Ravenna AUSL Romagna
Ravenna, Emilia Romagna, Italy, 48100
Ospedale Santa Maria degli Angeli
Pordenone, Friuli Venezia Giulia, Italy, 33170
Pediatric Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Ospedale Pediatrico IRCCS Bambino Gesú
Rome, Lazio, Italy, 00165
Istituto G. Gaslini
Genova, Liguria, Italy, 16120
Fondazione MBBM c/o Ospedale San Gerardo
Monza, Lombardia, Italy, 20900
Ospedale Provinciale di Macerata
Macerata, Marche, Italy, 62100
Ospedale Principe di Piemonte Area Vasta 2
Senigallia, Marche, Italy, 60019
Ospedale A. Cardarelli
Campobasso, Molise, Italy, 86170
Ospedale Infantile Regina Margherita
Torino, Piemonte, Italy, 10100
Ospedale Castelli
Verbania, Piemonte, Italy, 28992
Ospedale Giovanni Paolo II
Olbia, Sardegna, Italy, 07026
Azienda Ospedaliera di Padova
Padova, Veneto, Italy, 35100
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Chair: Egidio Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Stefania Norbedo, MD IRCCS Burlo Garofolo, Trieste, Italy
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Responsible Party: Luca Ronfani, Head of Clinical Epidemiology and Public Health Research Unit, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT03015051    
Other Study ID Numbers: High flow RCT
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Luca Ronfani, IRCCS Burlo Garofolo:
Bronchiolitis
High flow nasal cannula
Oxygen therapy
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections