Clinical Trial: Nebulized 5% Hypertonic Saline for the Treatment of Bronchiolitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial
Brief Summary: The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.
Detailed Summary:
We conducted a double blind, randomized, parallel-group clinical trial to compare the efficacy and safety of hypertonic saline 3% and 5% versus normal saline for the treatment of acute bronchiolitis.
The study was conducted in the short stay unit of the Pediatric Emergency Center of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. The Center serves an average of 200,000 patients annually and manages 42 beds in the short stay unit. Patients admitted to the unit were assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis range from 6 to 168 hours.
Infants aged ≤18 months presenting to the unit for the treatment of moderate-severe viral bronchiolitis were eligible for the study. Moderate-severe bronchiolitis required having a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score of ≥ 4 on presentation.
Patients were excluded from the study if they had one or more of the following characteristics: Born preterm ≤34 weeks gestation, previous history of wheezing, steroid use within 48 hours of presentation, obtundation and progressive respiratory failure requiring ICU admission, history of apnea with in 24 hours before presentation, oxygen saturation ≤ 85% on room air at the time of recruitment, history of a diagnosis of chronic lung disease, congenital heart disease, or immunodeficiency.
The six attending physicians who covered the 18 beds in the respiratory section of the short stay unit were trained in scoring and its practical application on our bronchiolitis patients in the un
Sponsor: Hamad Medical Corporation
Current Primary Outcome: Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The treatments' severity scores at 24 hours and trend over time to 72 hours, 2 hours-post-nebulization severity scores trending over time, as well as safety measures [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Hamad Medical Corporation
Dates:
Date Received: November 18, 2009
Date Started: April 2007
Date Completion:
Last Updated: November 18, 2009
Last Verified: November 2009
