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

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ClinicalTrials.gov Identifier: NCT01238848
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : August 17, 2012
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiolitis Drug: Hypertonic saline Drug: Normal saline Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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%)


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization Days [ Time Frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days ]
    hospitalization days


Secondary Outcome Measures :
  1. 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)


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

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Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01238848    
Other Study ID Numbers: HGNPE-14-2010
First Posted: November 11, 2010    Key Record Dates
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:
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Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
 Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases