3% Hypertonic Saline Versus Normal Saline in Inpatient Bronchiolitis: A Randomized Controlled Trial

Abstract

a abstract BACKGROUND AND OBJECTIVES: Bronchiolitis, the most common reason for hospitalization in children younger than 1 year in the United States, has no proven therapies effective beyond supportive care. We aimed to investigate the effect of nebulized 3% hypertonic saline (HS) compared with nebulized normal saline (NS) on length of stay (LOS) in infants hospitalized with bronchiolitis. METHODS:We conducted a prospective, randomized, double-blind, controlled trial in an urban tertiary care children's hospital in 227 infants younger than 12 months old admitted with a diagnosis of bronchiolitis (190 completed the study); 113 infants were randomized to HS (93 completed the study), and 114 to NS (97 completed the study). Subjects received 4 mL nebulized 3% HS or 4 mL 0.9% NS every 4 hours from enrollment until hospital discharge. The primary outcome was median LOS. Secondary outcomes were total adverse events, subdivided as clinical worsening and readmissions.RESULTS: Patient characteristics were similar in groups. In intention-to-treat analysis, median LOS (interquartile range) of HS and NS groups was 2.1 (1.2-4.6) vs 2.1 days (1.2-3.8), respectively, P = .73. We confirmed findings with per-protocol analysis, HS and NS groups with 2.0 (1.3-3.3) and 2.0 days (1.2-3.0), respectively, P = .96. Seven-day readmission rate for HS and NS groups were 4.3% and 3.1%, respectively, P = .77. Clinical worsening events were similar between groups (9% vs 8%, P = .97).CONCLUSIONS: Among infants admitted to the hospital with bronchiolitis, treatment with nebulized 3% HS compared with NS had no difference in LOS or 7-day readmission rates.WHAT'S KNOWN ON THIS SUBJECT: Bronchiolitis, the most frequent reason for hospitalization for infants younger than 1 year of age, has no proven treatments beyond supportive care. Although early studies suggested a potential benefit from 3% hypertonic saline, more recent studies have conflicting results. WHAT THIS STUDY ADDS:This prospective, randomized, double-blind, controlled trial in infants admitted with bronchiolitis (including patients with a history of previous wheeze) demonstrated no difference in length of stay between those who received hypertonic saline or normal saline without bronchodilators.

Effect of Nebulized 3% Hypertonic Saline on Intensive Care Unit Admission Rates of Infants with Moderate Acute Bronchiolitis

“…However, this comparison was not the primary aim of any of these studies. Both of them, report an overall length of hospital stay similar to our series, but in contrast with our results, none of these two find a shorter length of stay in the group receiving 3% Hypertonic saline [20,21].…”

Early Halt of a Randomized Controlled Study with 3% Hypertonic Saline in Acute Bronchiolitis

“…In 1 retrospective study [17] , only 4 mild adverse effects and 1 episode of bronchospasm were noted on 377 delivered doses of 3% HS, but when this number is related to the number of treated infants ( n = 68), this concerns about 7% of the population. In another recent prospective study [24] where only 80% of the population corresponded to our criteria of bronchiolitis, a clinical worsening (defined as transfer to the pediatric intensive care unit or bronchospasm within 30 min of a nebulization) was observed in 9% of the infants treated with 3% HS. We have also observed many minor adverse events; some of them, such as tears, agitation, and/or coughing during inhalation, may additionally compromise the theoretical efficacy of the 3% HS by limiting the penetration of the aerosol into the respiratory tree and then by negatively affecting its bronchial deposition.…”

“…Secondly, the nebulization effect itself could be questioned. Although 2 studies showed a Wang score decrease 30 min after the beginning of a nebulization with 3% HS and bronchodilators [4,12] , recent data show that a normal saline nebulization induces comparable clinical worsening events as a 3% HS nebulization [24] . Collecting data before and after a nebulization with only 3% HS would be helpful to support this hypothesis.…”

Comparing the efficacy of 7%, 5% hypertonic saline and 0.9% normal saline in acute bronchiolitis: a randomized controlled trial

“…[8][9][10][11][12][13][14][15][16][17][18][19] Many studies showed that 5% HS in treatment of bronchiolitis in children is better than 0.9% NS. 8,20,21 Jacobs et al, conducted a clinical trial and showed that use of 7% HS with epinephrine did not have a considerable effect on the severity and LOS of the infants under 18 months with viral bronchiolitis which not in line with our study results.…”