NCT00677729|CompletedPhase 2DMC
Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis
Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
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Sponsor study identifier
Secondary identifiers
interventional
81
1 country
3
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay. Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced. Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2, 2008
Actual (reported)May 14, 2008
Actual (reported)November 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 2009
Actual (reported)May 2009
Actual (reported)compare the rate of admission to hospital between the study and control groups
1 hour after treatment ends
change in the RDAI between study entry and post-treatment.
1 hour after treatment ends
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl)
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl)
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses
The Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston
Kingston, Ontario, Canada
Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
Brian Kuzik, MD
The Royal Victoria Hospital of Barrie
81 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2008
First Posted
May 14, 2008
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
November 13, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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