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

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.
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):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bronchiolitis
Interventions: Drug: Hypertonic saline
Drug: Normal saline

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      50 100.0%      50 100.0%      100 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Months]
Mean (Standard Deviation)
 4.6  (4.1)   4.2  (2.5)   4.5  (3.8) 
Gender 
[Units: Participants]
Count of Participants
     
Female      24  48.0%      26  52.0%      50  50.0% 
Male      26  52.0%      24  48.0%      50  50.0% 


  Outcome Measures

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

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
The initially estimated sample size was not achieved


  More Information

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
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