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HS in ER Study
NCT00677729Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2008
- Primary completion
- Apr 2009
- Countries
- 1
- Sponsor
- Queen's University
- Modality
- Small Molecules, Device-based Delivery
- Drugs
- hypertonic saline
- Conditions
- viral bronchiolitis
01
Overview
Phase 2, randomised, double-blind trial of hypertonic saline in viral bronchiolitis (2 arms), sponsored by Queen's University. Primary endpoint: Rate of admission to hospital. Started Nov 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
3% HS Group
Salbutamol + 3% Hypertonic Saline
0.9% NS Group
Salbutamol + 0.9% Normal Saline
03
Who it enrols
Infants < 24 months with moderately severe viral bronchiolitis (wheezing/crackles, RDAI > 4 or SaO2 < 94%) and no history of chronic cardiopulmonary disease, immunodeficiency, or prematurity (<34 weeks).
04
Endpoints
Primary
Rate of admission to hospital
Secondary
Change in Respiratory Distress Assessment Instrument (RDAI)
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