Title

Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis
A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    sodium chloride ...
  • Study Participants

    82
The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.
Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.
Study Started
Dec 31
2010
Primary Completion
Oct 31
2011
Study Completion
May 31
2012
Results Posted
Aug 17
2012
Estimate
Last Update
Feb 10
2017

Drug Hypertonic saline

3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

  • Other names: ClNa 3% (sodium chloride 3%)

Drug Normal saline

3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

  • Other names: ClNa 0.9% (sodium chloride 0.9%)

Hypertonic Experimental

Nebulized hypertonic saline (sodium chloride 3%) + albuterol

Normal Active Comparator

Normal saline (sodium chloride 0.9%) + albuterol

Criteria

Inclusion criteria:

Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria:

Chronic respiratory or cardiovascular disease, respiratory failure.

Summary

Hypertonic

Normal

All Events

Event Type Organ System Event Term

Hospitalization Days

hospitalization days

Hypertonic

5.8
days (Median)
Standard Deviation: 2.7

Normal

5.47
days (Median)
Standard Deviation: 2.1

Length of Oxygen Use

Length of oxygen use (days)

Hypertonic

4.0
days (Median)
Standard Deviation: 3.4

Normal

3.22
days (Median)
Standard Deviation: 2.3

Total

100
Participants

Age, Continuous

4.5
months (Mean)
Standard Deviation: 3.8

Age, Categorical

Gender

Overall Study

Hypertonic

Normal

Drop/Withdrawal Reasons

Hypertonic

Normal