OBJECTIVE: To evaluate the short and long-term clinical effects and the treatment-feasibility of inhaled-furosemide (IF) as compared with placebo via hood in hospitalized infants with viral-bronchiolitis (VB). STUDY- DESIGN: A randomized, double-blind, placebo-controlled pilot-study was performed in previously healthy infants (0-12 months). Enrolled infants were randomized to receive either IF (2 mg/kg), or placebo nebulized by hood three times daily throughout the hospitalization. Clinical assessment (respiratory distress assessment instrument [RDAI]) was performed before, 30 and 60 min after the 1st daily inhalation. The short-term effects were evaluated by the RDAI, respiratory assessment change score (RACS) and oxygen requirement and the long-term effects by time to be weaned off oxygen, time to full enteral feeding, length of stay, and "ready to discharge" time. RESULTS: Both groups (16 infants each) had comparable characteristics at study entry. Mean (+/-SD) age was 72 +/- 43 days, and 29/32 infants were RSV positive. Oxygen requirement (FiO(2)) decreased significantly at 30 min post-inhalation (30 +/- 9.2% to 26 +/- 7.1%, P < 0.05) only in the IF group. RACSs and long-term effects of both groups were comparable. Analysis of IF particles generated by the hood-nebulizer demonstrated that 36% and 49% of the particles were <3 and 5 microm, respectively. No side effects were observed during IF treatment. CONCLUSION: Based on our pilot study, IF has no significant clinical effects in hospitalized infants with VB. IF via hood seems to be feasible and safe. (c) 2008 Wiley-Liss, Inc.
RCT Entities:
OBJECTIVE: To evaluate the short and long-term clinical effects and the treatment-feasibility of inhaled-furosemide (IF) as compared with placebo via hood in hospitalized infants with viral-bronchiolitis (VB). STUDY- DESIGN: A randomized, double-blind, placebo-controlled pilot-study was performed in previously healthy infants (0-12 months). Enrolled infants were randomized to receive either IF (2 mg/kg), or placebo nebulized by hood three times daily throughout the hospitalization. Clinical assessment (respiratory distress assessment instrument [RDAI]) was performed before, 30 and 60 min after the 1st daily inhalation. The short-term effects were evaluated by the RDAI, respiratory assessment change score (RACS) and oxygen requirement and the long-term effects by time to be weaned off oxygen, time to full enteral feeding, length of stay, and "ready to discharge" time. RESULTS: Both groups (16 infants each) had comparable characteristics at study entry. Mean (+/-SD) age was 72 +/- 43 days, and 29/32 infants were RSV positive. Oxygen requirement (FiO(2)) decreased significantly at 30 min post-inhalation (30 +/- 9.2% to 26 +/- 7.1%, P < 0.05) only in the IF group. RACSs and long-term effects of both groups were comparable. Analysis of IF particles generated by the hood-nebulizer demonstrated that 36% and 49% of the particles were <3 and 5 microm, respectively. No side effects were observed during IF treatment. CONCLUSION: Based on our pilot study, IF has no significant clinical effects in hospitalized infants with VB. IF via hood seems to be feasible and safe. (c) 2008 Wiley-Liss, Inc.