OBJECTIVES: To determine whether the use of albuterol by nebulization enhances physiologic or clinical recovery in hospitalized infants with moderate bronchiolitis. METHODS: This prospective, double-blind, placebo-controlled, randomized clinical trial was performed from December 1995 to March 1996. A total of 52 patients <24 months of age with a diagnosis of moderately severe, acute viral bronchiolitis were enrolled and assigned to receive nebulized albuterol or normal saline placebo for 72 hours under a standardized protocol. Primary outcome measures included improvement in oxygen saturation (SaO2) during hospitalization and survival analysis to assess the time required to reach preestablished discharge criteria on three measures: SaO2, accessory muscle use, and wheezing. An additional secondary outcome measure was actual length of hospital stay. Adverse outcomes also were compared between treatment groups. RESULTS: There was no significant difference in mean SaO2 between albuterol and placebo at baseline, 24 hours, or maximum SaO2 achieved during hospitalization. Both groups showed significant improvement in oxygen saturation over time, but there was no significant difference in improvement between the two groups. The study had a power of 90% to detect a difference in mean percentage point improvement of 2% SaO2. There was no difference in time to reach discharge criteria as defined by SaO2, accessory muscle use, or wheezing. There was no difference in length of hospital stay or in the frequency of adverse outcomes. CONCLUSIONS:Nebulized albuterol therapy does not appear to enhance recovery or attenuate severity of illness in infants hospitalized with acute, moderate bronchiolitis, as evidenced by improvement in oxygen saturation, time to meet standardized discharge criteria, or length of hospital stay.
RCT Entities:
OBJECTIVES: To determine whether the use of albuterol by nebulization enhances physiologic or clinical recovery in hospitalized infants with moderate bronchiolitis. METHODS: This prospective, double-blind, placebo-controlled, randomized clinical trial was performed from December 1995 to March 1996. A total of 52 patients <24 months of age with a diagnosis of moderately severe, acute viral bronchiolitis were enrolled and assigned to receive nebulized albuterol or normal saline placebo for 72 hours under a standardized protocol. Primary outcome measures included improvement in oxygen saturation (SaO2) during hospitalization and survival analysis to assess the time required to reach preestablished discharge criteria on three measures: SaO2, accessory muscle use, and wheezing. An additional secondary outcome measure was actual length of hospital stay. Adverse outcomes also were compared between treatment groups. RESULTS: There was no significant difference in mean SaO2 between albuterol and placebo at baseline, 24 hours, or maximum SaO2 achieved during hospitalization. Both groups showed significant improvement in oxygen saturation over time, but there was no significant difference in improvement between the two groups. The study had a power of 90% to detect a difference in mean percentage point improvement of 2% SaO2. There was no difference in time to reach discharge criteria as defined by SaO2, accessory muscle use, or wheezing. There was no difference in length of hospital stay or in the frequency of adverse outcomes. CONCLUSIONS: Nebulized albuterol therapy does not appear to enhance recovery or attenuate severity of illness in infants hospitalized with acute, moderate bronchiolitis, as evidenced by improvement in oxygen saturation, time to meet standardized discharge criteria, or length of hospital stay.
Authors: J Carlos Flores-González; Miguel A Matamala-Morillo; Patricia Rodríguez-Campoy; Juan J Pérez-Guerrero; Belén Serrano-Moyano; Paloma Comino-Vazquez; Encarnación Palma-Zambrano; Rocio Bulo-Concellón; Vanessa Santos-Sánchez; Alfonso M Lechuga-Sancho Journal: PLoS One Date: 2015-11-17 Impact factor: 3.240