A Phase 2 interventional study of solution contains 1 mg salbutamol plus 3% hypertonic saline and solution contains 1 mg salbutamol plus 0.9% saline in Viral Bronchiolitis, sponsored by Queen's University. Completed at 3 sites in Canada. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2015-11-13.
Sponsored by Queen's University · Phase 2, Interventional, and Treatment
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.
Patients presenting to the Emergency Room (ER) or out-patient department with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. After the initial routine assessment by the ER medical and nursing staff, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion with 4 ml of nebulized study solution containing 1 mg salbutamol (bronchodilator) plus either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 3 doses. After an observation period of 1 hour following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home, remain in ER for further treatment) at which point the infant's active involvement in the study will end. All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 7 days later to assess resolution of symptoms or the presence of any unexpected adverse effects.
Clinical response to the above treatment will also be determined independently by the study physician or designate utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after the post-treatment observation period. The primary outcome measure is to compare the rate of admission to hospital between the study and control groups. A secondary outcome measure will involve the assessment of change in the RDAI between study entry and post-treatment.
The infant will remain in the ER throughout the study period and receive standard ongoing monitoring by the nursing staff. In the unlikely event of significant clinical worsening during this period, the ER physician on duty will be notified to assess and intervene as he/she feels appropriate. The site study investigator will be immediately notified of all such occurrences by the research assistant involved.
The study will be conducted over a single bronchiolitis season from November 1, 2008 to April 1, 2009. There will be 2 study sites as listed below with the name of the study site director.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 81 is close to the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:
Patient exclusion criteria:
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl)
Drug: solution contains 1 mg salbutamol plus 3% hypertonic saline
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl)
Drug: solution contains 1 mg salbutamol plus 0.9% saline
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
compare the rate of admission to hospital between the study and control groups
Time frame: 1 hour after treatment ends
change in the RDAI between study entry and post-treatment.
Time frame: 1 hour after treatment ends
The record gives a start of Nov 2008, a primary completion of Apr 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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