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

Pediatrics. 2015 Dec;136(6):1036-43. doi: 10.1542/peds.2015-1037. Epub 2015 Nov 9.

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.

Trial registration: ClinicalTrials.gov NCT01488448.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Bronchiolitis / drug therapy*
  • Bronchodilator Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Inpatients
  • Isotonic Solutions / therapeutic use*
  • Length of Stay
  • Male
  • Nebulizers and Vaporizers
  • Prospective Studies
  • Saline Solution, Hypertonic / therapeutic use*
  • Sodium Chloride / therapeutic use*
  • Treatment Outcome

Substances

  • Bronchodilator Agents
  • Isotonic Solutions
  • Saline Solution, Hypertonic
  • Sodium Chloride

Associated data

  • ClinicalTrials.gov/NCT01488448