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High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

This study is currently recruiting participants.
Verified January 2017 by Luca Ronfani, IRCCS Burlo Garofolo
Sponsor:
ClinicalTrials.gov Identifier:
NCT03015051
First Posted: January 9, 2017
Last Update Posted: January 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Luca Ronfani, IRCCS Burlo Garofolo
  Purpose

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 Intervention Phase
Bronchiolitis Drug: Oxygen Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Luca Ronfani, IRCCS Burlo Garofolo:

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

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

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


Estimated Enrollment: 130
Study Start Date: January 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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


Contacts
Contact: Egidio Barbi, MD +390403785333 ebarbi@libero.it
Contact: Stefania Norbedo, MD +390403785333 stedoc@yahoo.it

Locations
Italy
Ospedale Maggiore Not yet recruiting
Bologna, Emilia Romagna, Italy, 40133
Contact: Elisa Mazzoni, MD       e.mazzoni@ausl.bologna.it   
Ospedale Morgagni-Pierantoni Not yet recruiting
Forlì, Emilia Romagna, Italy, 47100
Contact: Francesca Vaienti, MD    0543731789    francescavaienti@libero.it   
Ospedale Ravenna AUSL Romagna Not yet recruiting
Ravenna, Emilia Romagna, Italy, 48100
Contact: Lorenzo Mambelli, MD       lorenzo.mambelli@auslromagna.it   
Ospedale Santa Maria degli Angeli Not yet recruiting
Pordenone, Friuli Venezia Giulia, Italy, 33170
Contact: Valentina Declich, MD    0434399785    valentinadeclich@libero.it   
Pediatric Emergency Department, IRCCS Burlo Garofolo Recruiting
Trieste, Friuli Venezia Giulia, Italy, 34137
Contact: Egidio Barbi, MD    +390403785333    ebarbi@libero.it   
Ospedale Pediatrico IRCCS Bambino Gesú Not yet recruiting
Rome, Lazio, Italy, 00165
Contact: Emanuele Giglioni, MD       emanuele.giglioni@opbg.net   
Istituto G. Gaslini Not yet recruiting
Genova, Liguria, Italy, 16120
Contact: Salvatore Renna, MD       salvatorerenna@ospedale-gaslini.ge.it   
Fondazione MBBM c/o Ospedale San Gerardo Not yet recruiting
Monza, Lombardia, Italy, 20900
Contact: Maria Luisa Melzi, MD    +390392333511    m.melzi@hsgerardo.org   
Ospedale Provinciale di Macerata Not yet recruiting
Macerata, Marche, Italy, 62100
Contact: Paolo Francesco Perri, MD       paolofrancesco.perri@sanita.marche.it   
Ospedale Principe di Piemonte Area Vasta 2 Not yet recruiting
Senigallia, Marche, Italy, 60019
Contact: Alessandro Volpini, MD       alessandro.volpini@sanita.marche.it   
Ospedale A. Cardarelli Not yet recruiting
Campobasso, Molise, Italy, 86170
Contact: Debora Simonetti, MD       deboramlsim@yahoo.it   
Ospedale Infantile Regina Margherita Not yet recruiting
Torino, Piemonte, Italy, 10100
Contact: Irene Tardivo, MD    +390113135059    irenetardivo@libero.it   
Ospedale Castelli Not yet recruiting
Verbania, Piemonte, Italy, 28992
Contact: Andrea Guala, MD       andrea.guala@aslvco.it   
Ospedale Giovanni Paolo II Not yet recruiting
Olbia, Sardegna, Italy, 07026
Contact: Marta Agnese Bernassola, MD       mbernassola@aslolbia.it   
Azienda Ospedaliera di Padova Not yet recruiting
Padova, Veneto, Italy, 35100
Contact: Tiziana Zangardi, MD       tiziana.zangardi@sanita.padova.it   
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Study Chair: Egidio Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Stefania Norbedo, MD IRCCS Burlo Garofolo, Trieste, Italy
  More Information

Responsible Party: Luca Ronfani, Head of Clinical Epidemiology and Public Health Research Unit, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT03015051     History of Changes
Other Study ID Numbers: High flow RCT
First Submitted: November 24, 2016
First Posted: January 9, 2017
Last Update Posted: January 16, 2017
Last Verified: January 2017
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:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections