Clinical Trial: Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
Brief Summary:
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.
Detailed Summary:
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 duri
Sponsor: Queen's University
Current Primary Outcome: compare the rate of admission to hospital between the study and control groups [ Time Frame: 1 hour after treatment ends ]
Original Primary Outcome: Same as current
Current Secondary Outcome: change in the RDAI between study entry and post-treatment. [ Time Frame: 1 hour after treatment ends ]
Original Secondary Outcome: Same as current
Information By: Queen's University
Dates:
Date Received: May 2, 2008
Date Started: November 2008
Date Completion:
Last Updated: November 12, 2015
Last Verified: November 2015
