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Clinical Trials/NCT03015051
NCT03015051
Terminated
Phase 4

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

IRCCS Burlo Garofolo15 sites in 1 country30 target enrollmentJanuary 2017
ConditionsBronchiolitis
InterventionsOxygen
DrugsOxygen

Overview

Phase
Phase 4
Intervention
Oxygen
Conditions
Bronchiolitis
Sponsor
IRCCS Burlo Garofolo
Enrollment
30
Locations
15
Primary Endpoint
Hours of oxygen therapy
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
December 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
IRCCS Burlo Garofolo
Responsible Party
Principal Investigator
Principal Investigator

Luca Ronfani

Head of Clinical Epidemiology and Public Health Research Unit

IRCCS Burlo Garofolo

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)

Arms & Interventions

High flow

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

Intervention: Oxygen

Low flow

Low flow (max 3 L/min) oxygen therapy

Intervention: Oxygen

Outcomes

Primary Outcomes

Hours of oxygen therapy

Time Frame: up to 5 days

Secondary Outcomes

  • 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(up to 5 days)
  • Adverse events(up to 15 days)

Study Sites (15)

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