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Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis (Hypertonic)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238848
First Posted: November 11, 2010
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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% (sodium chloride 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% (sodium chloride 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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 9, 2010
First Posted: November 11, 2010
Results First Submitted: July 16, 2012
Results First Posted: August 17, 2012
Last Update Posted: February 10, 2017
Last Verified: July 2012

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
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action