Use of nebulized bronchodilators in infants under 1 year of age: analysis of four forms of therapy. A randomized, controlled trial of nebulized terbutaline for the first acute bronchiolitis in infants less than 12-months-old.
The main purpose of this study was to evaluate four different forms of treatment in young infants admitted for acute wheezing (AW). Seventy-nine infants less than one year of age were randomly assigned to one of five groups. Group 1 received nebulized fenoterol plus ipratropium bromide, group 2 fenoterol, group 3 fenoterol plus steroids, and group 4 aminophylline, IV, plus steroids and oral fenoterol; the control group, or group 5, received nebulized normal saline solution. Clinical evaluation was done by means of a scoring system. The effectiveness of treatments was estimated by a score decrease in the first 24 hours, by the percentage of patients whose scores did not decrease during the same period, and by the number of days in the hospital. All infants had significantly decreased scores, except those in the control group; the aminophylline group included a greater percentage of patients who did not abate their scores, and they stayed in the hospital for more days than those in the other groups. The fenoterol group had the shortest hospital stay. All four treatments produced objective clinical improvement in bronchial obstruction. However, the nebulized bronchodilator treatments were more effective than aminophylline IV in decreasing scores on the first day, and they resulted in shorter hospitalization. Despite the common clinical practice, the available evidence on the efficacy of bronchodilators therapy for bronchiolitis is conflicting. The aim of this study is to evaluate the efficacy of nebulized terbutaline in bronchiolitis as measured by improvement in clinical score, oxygen saturation or reduction in duration of hospitalization.
                This prospective, double blind, placebo controlled, randomized clinical trial was performed at Children's Hospital of Tunis from December 2004 to April 2006. A total of 35 patients less than 12 months of age with diagnosis of moderately severe bronchiolitis were enrolled and assigned to receive nebulized terbutaline or normal saline placebo at admission (T0), at 30 minutes after admission (T30) and every four hours during a study period. Outcome measurements included: Respiratory Distress Assessment Instrument (RDAI) score, respiratory rate, oxygen saturation, heart rate and the duration of hospitalization.
                There were no significant difference between terbutaline and placebo at baseline, T30 min, T60 min, and T120 min after start study in RDAI score, oxygen saturation in room air, rate respiratory and heart rate. There was no difference in duration of hospitalization.
                Nebulized terbutaline therapy does not appear effective in treating moderately ill infants with the first acute bronchiolitis.
The results based on the three included studies in this review did not support the use of nebulised rhDNase in children under 24 months of age hospitalised with acute bronchiolitis. In these patients, treatment did not shorten the length of hospitalisation or improve clinical outcomes. It might have a role in severe bronchiolitis complicated by atelectasis, but further clinical studies would need to be performed.