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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

Tracking Information
First Submitted Date  ICMJE November 24, 2016
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Hours of oxygen therapy [ Time Frame: up to 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis
Official Title  ICMJE Randomized Controlled Trial to Compare the Efficacy of High Flow Nasal Cannula Oxygen Therapy vs Low Flow Oxygen Therapy in Bronchiolitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchiolitis
Intervention  ICMJE Drug: Oxygen
Study Arms  ICMJE
  • Experimental: High flow
    High flow (2 L/kg/min) nasal cannula oxygen therapy
    Intervention: Drug: Oxygen
  • Active Comparator: Low flow
    Low flow (max 3 L/min) oxygen therapy
    Intervention: Drug: Oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
130
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015051
Other Study ID Numbers  ICMJE High flow RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Luca Ronfani, IRCCS Burlo Garofolo
Study Sponsor  ICMJE IRCCS Burlo Garofolo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Egidio Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Stefania Norbedo, MD IRCCS Burlo Garofolo, Trieste, Italy
PRS Account IRCCS Burlo Garofolo
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP