Try our beta test site

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

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: December 20, 2016
Last verified: July 2012
Results First Received: July 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bronchiolitis
Interventions: Drug: Hypertonic saline
Drug: Normal saline

  Participant Flow
  Hide 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
  Hide 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
  Show All 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
  Hide 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
  Hide 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
Study First Received: November 9, 2010
Results First Received: July 16, 2012
Last Updated: December 20, 2016