Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis

Abstract

for the Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) Study Group IMPORTANCE Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED).OBJECTIVE To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis. DESIGN, SETTING, AND PARTICIPANTSThe Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included.INTERVENTIONS Two 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart. MAIN OUTCOMES AND MEASURESHospital admission rate in the 24 hours after enrollment. RESULTSOf the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95% CI, -8.7% to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95% CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group (35 of 392 [8.9%]) than among those in the NS group (15 of 384 [3.9%]) (risk difference, 5.0%; 95% CI, 1.6%-8.4%; P = .005), with no serious adverse events.CONCLUSIONS AND RELEVANCE Nebulized HS treatment did not significantly reduce the rate of hospital admissions among infants with a first episode of acute moderate to severe bronchiolitis who were admitted to the pediatric ED relative to NS, but mild adverse events were more frequent in the HS group. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01777347

Impact of hypertonic saline on hospitalization rate in infants with acute bronchiolitis: A meta‐analysis

“…Table shows the results of subgroup analyses. A significant effect of HS in reducing the risk of hospitalization was found only in the pooled analyses of trials in which HS was mixed with bronchodilators, multiple doses (≥3) were given, and risk of bias was low …”

“…No serious adverse events (AEs) were reported. Three trials reported at least one event, and worsening of cough was the most frequently reported minor AEs which occurred in 6.6% of patients treated with HS and 0.8% of patients treated with NS …”

“…Two large trials contributed 62% to the weight of the current meta‐analysis, but they presented inconsistent results. Both trials were generally well‐designed and conducted.…”

Pediatric Pulmonology year in review 2017: Part 3

“…Another scoring system, the modified Respiratory Index Score (RIS), was found to be a reasonable predictor of the need for hospital admission in a single‐center study in Singapore . A large multicenter clinical trial did not show any benefit of nebulized hypertonic saline for reduction of hospital admissions in acute bronchiolitics in an emergency department setting . In a review, Hancock et al pointed out the ongoing heterogeneity of definitions used for viral bronchiolitis in published literature, which continues to hamper comparisons among studies.…”

Hypertonic saline in viral wheezing

“…There is increasing evidence—based on new RCT studies and most recent meta‐analyses—that HS inhalations are not useful in bronchiolitis in infants . The multicenter SABRE study form UK compared 141 infants hospitalized for bronchiolitis at less than 12 months of age and treated with HS inhalations 6‐h, with 159 control infants treated with “minimal handling” standard care without any inhalations .…”