Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01238848
First received: November 9, 2010
Last updated: July 16, 2012
Last verified: July 2012

November 9, 2010
July 16, 2012
December 2010
October 2011   (final data collection date for primary outcome measure)
Hospitalization Days [ Time Frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days ] [ Designated as safety issue: No ]
hospitalization days
Length of hospital stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
Length of hospital stay (in days)
Complete list of historical versions of study NCT01238848 on ClinicalTrials.gov Archive Site
Length of Oxygen Use [ Time Frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days ] [ Designated as safety issue: No ]
Length of oxygen use (days)
  • Length of oxygen use [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
    Length of oxygen use (days)
  • Clinical outcome [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
    Modification on admission clinical severity score
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bronchiolitis
  • Drug: Hypertonic saline
    3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
    Other Name: ClNa 3%
  • Drug: Normal saline
    3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
    Other Name: ClNa 0.9%
  • Experimental: Hypertonic
    Nebulized hypertonic saline (sodium chloride 3%) + albuterol
    Intervention: Drug: Hypertonic saline
  • Active Comparator: Normal
    Normal saline (sodium chloride 0.9%) + albuterol
    Intervention: Drug: Normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
May 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
1 Month to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01238848
HGNPE-14-2010
Yes
Hospital General de Niños Pedro de Elizalde
Hospital General de Niños Pedro de Elizalde
Not Provided
Principal Investigator: Maria I Espelt, MD Hospital General de Niños Pedro de Elizalde
Hospital General de Niños Pedro de Elizalde
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP