Viral respiratory distress in infants < 6 months treated with high or low fluxes of oxyge

Phase 1

• Conditions: Bronchiolitis; MedDRA version: 18.1Level: PTClassification code 10006448Term: BronchiolitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-003093-32-IT
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-14
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified