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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
History of Changes
  Purpose

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.


Condition Intervention
Bronchiolitis
 Drug: Hypertonic saline
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis

Further study details as provided by Hospital General de Niños Pedro de Elizalde:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 82
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypertonic
Nebulized hypertonic saline (sodium chloride 3%) + albuterol
 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%
Active Comparator: Normal
Normal saline (sodium chloride 0.9%) + albuterol
 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%

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Month to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238848

Locations
Argentina
Hospital General de Niños Pedro de Elizalde
Buenos Aires, CF, Argentina, C1270AAN
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Maria I Espelt, MD Hospital General de Niños Pedro de Elizalde
  More Information

Publications:

Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01238848     History of Changes
Other Study ID Numbers: HGNPE-14-2010
Study First Received: November 9, 2010
Results First Received: July 16, 2012
Last Updated: July 16, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital General de Niños Pedro de Elizalde:
Hypertonic
Saline
Bronchiolitis
Efficacy

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 22, 2013