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
Results First Received: July 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bronchiolitis
Interventions: Drug: Hypertonic saline
Drug: Normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hypertonic Hypertonic saline (sodium chloride 0.3%) + albuterol
Normal Normal saline (sodium chloride 0.9%) + albuterol

Participant Flow:   Overall Study
    Hypertonic     Normal  
STARTED     50     50  
COMPLETED     37     45  
NOT COMPLETED     13     5  
Physician Decision                 13                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hypertonic Hypertonic saline (sodium chloride 0.3%) + albuterol
Normal Normal saline (sodium chloride 0.9%) + albuterol
Total Total of all reporting groups

Baseline Measures
    Hypertonic     Normal     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: participants]
     
<=18 years     50     50     100  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  2  ± 1     2  ± 1     2  ± 1  
Gender  
[units: participants]
     
Female     24     26     50  
Male     26     24     50  



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

2.  Secondary:   Length of Oxygen Use   [ Time Frame: Participants will be followed for the duration of hospitalization, an expected average of 4 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
not obtained the estimated number of patients because many of them were left out of the study due to torpid evolution. So physitians decided to took them out of the study


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maria I. Espelt, MD
Organization: Hospital General de Niños Pedro de Elizalde
phone: 541146136968
e-mail: cespelt@fibertel.com.ar


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