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Clinical Trials/EUCTR2015-003093-32-IT
EUCTR2015-003093-32-IT
Active, not recruiting
Phase 1

Randomized controlled trial to evaluate the efficacy of high flow versus low flow oxygen therapy in bronchiolitis - High or low fluxes of Oxygen in Bronchiolitis

IRCCS Burlo Garofolo0 sites130 target enrollmentJanuary 14, 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bronchiolitis
Sponsor
IRCCS Burlo Garofolo
Enrollment
130
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 14, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IRCCS Burlo Garofolo

Eligibility Criteria

Inclusion Criteria

  • Subjects diagnosed with bronchiolitis who present at the Emergency Departments with the following inclusion criteria:
  • Diagnosis of bronchiolitis
  • Age \<6 months
  • SaO2 \<92%
  • Respiratory rate\> 60 breaths / min
  • severe dyspnea (RDAI score \=8\)
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 130
  • F.1\.2 Adults (18\-64 years) no
  • F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • Exclusion criteria will be the presence of:
  • syndromes and chronic diseases
  • respiratory diseases (eg. Broncodisplasie)
  • heart disease
  • preterm birth (patients born before 36 weeks of gestational age)

Outcomes

Primary Outcomes

Not specified

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