Todd A Florin1, Kathy N Shaw2, Marlena Kittick3, Stephen Yakscoe3, Joseph J Zorc2. 1. Division of Pediatric Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio2Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, Ohio. 2. Division of Pediatric Emergency Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania4Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia. 3. Division of Pediatric Emergency Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Abstract
IMPORTANCE: Acute bronchiolitis is the most frequent lower respiratory tract infection in infants, yet there are no effective therapies available. Current evidence is unclear about the role of hypertonic saline (HS) for the acute treatment of bronchiolitis. OBJECTIVE: To determine whether nebulized 3% HS compared with normal saline (NS) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial with blinding of investigators, health care providers, and parents was conducted at a single urban pediatric ED. The participants included children aged 2 to less than 24 months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of 4 to 15 after nasal suctioning and a trial ofnebulized albuterol. INTERVENTIONS: Patients were randomized to receive either nebulized 3% HS (HS group) or NS (NS group). MAIN OUTCOMES AND MEASURES: The primary outcome was change in respiratory distress at 1 hour after the intervention, as measured by the Respiratory Assessment Change Score (a decrease indicates improvement). Secondary outcomes included vital signs, oxygen saturation, hospitalization, physician clinical impression, parental assessment, and adverse events. RESULTS: The 31 patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics. At 1 hour after the intervention, the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group (HS, -1 [interquartile range, -5 to 1] vs. NS, -5 [interquartile range, -6 to -2]; P = .01). There were no significant differences in heart rate, oxygen saturation, hospitalization rate, or other outcomes. There were no adverse events. CONCLUSIONS AND RELEVANCE: Infants with bronchiolitis and persistentrespiratory distress after standard treatment in the emergency department had less improvement after receiving 3% HS compared with those who received NS. Based on these results and the existing evidence, administration of a single dose of 3% HS does not appear to be indicated to treat bronchiolitis in the acute care setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01247064.
RCT Entities:
IMPORTANCE: Acute bronchiolitis is the most frequent lower respiratory tract infection in infants, yet there are no effective therapies available. Current evidence is unclear about the role of hypertonic saline (HS) for the acute treatment of bronchiolitis. OBJECTIVE: To determine whether nebulized 3% HS compared with normal saline (NS) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial with blinding of investigators, health care providers, and parents was conducted at a single urban pediatric ED. The participants included children aged 2 to less than 24 months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of 4 to 15 after nasal suctioning and a trial of nebulized albuterol. INTERVENTIONS:Patients were randomized to receive either nebulized 3% HS (HS group) or NS (NS group). MAIN OUTCOMES AND MEASURES: The primary outcome was change in respiratory distress at 1 hour after the intervention, as measured by the Respiratory Assessment Change Score (a decrease indicates improvement). Secondary outcomes included vital signs, oxygen saturation, hospitalization, physician clinical impression, parental assessment, and adverse events. RESULTS: The 31 patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics. At 1 hour after the intervention, the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group (HS, -1 [interquartile range, -5 to 1] vs. NS, -5 [interquartile range, -6 to -2]; P = .01). There were no significant differences in heart rate, oxygen saturation, hospitalization rate, or other outcomes. There were no adverse events. CONCLUSIONS AND RELEVANCE: Infants with bronchiolitis and persistent respiratory distress after standard treatment in the emergency department had less improvement after receiving 3% HS compared with those who received NS. Based on these results and the existing evidence, administration of a single dose of 3% HS does not appear to be indicated to treat bronchiolitis in the acute care setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01247064.
Authors: Todd A Florin; Terri Byczkowski; Richard M Ruddy; Joseph J Zorc; Matthew Test; Samir S Shah Journal: J Pediatr Date: 2015-03-04 Impact factor: 4.406