Status:
COMPLETED
High Flow Therapy vs Hypertonic Saline in Bronchiolitis
Lead Sponsor:
Ministry of Health, Spain
Conditions:
Acute Viral Bronchiolitis
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiol...
Eligibility Criteria
Inclusion
- Children aged 6 months or less
- Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
- Meeting Admission criteria
Exclusion
- History of prematurity
- Chronic lung disease
- Cystic fibrosis
- Congenital heart disease
- Neuromuscular disease
- Airway anomalies
- Immunodeficiency
- Those requiring immediate intubation and ventilation.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01873144
Start Date
October 1 2010
End Date
December 1 2012
Last Update
June 7 2013
Active Locations (2)
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1
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain, 28922
2
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28911