Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
3% hypertonic saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, 3% Hypertonic Saline Solution
Eligibility Criteria
Inclusion Criteria:
- children aged less than 2 years old
- clinical diagnosis of bronchiolitis
Exclusion Criteria:
- cardiac or pulmonary diseases
- premature birth < 36 weeks of gestational age
- previous diagnosis of asthma
- an initial oxygen saturation of 85%
Sites / Locations
- Azienda Sanitaria Locale Napoli 2 Nord
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
No Intervention
Arm Label
0.9% saline
3% hypertonic saline
Arm Description
patients receive every 6 hours the nebulized 0.9% saline (placebo comparator) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
Outcomes
Primary Outcome Measures
time of hospitalization
length of stay
Secondary Outcome Measures
Clinical response before and 30 minutes after nebulisation by score
Full Information
NCT ID
NCT01300325
First Posted
February 18, 2011
Last Updated
February 18, 2011
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT01300325
Brief Title
Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis
Official Title
Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization in children younger than 2 years. In the United States it has been shown that the burden of the disease is considerable, having an annual cost of more than $ 500 million and being responsible for the 17% of all infant hospitalizations . Aim of the present study was to verify the effects of nebulized 3% saline solution in comparison to normal saline in addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all patients presented a disease as much as severe to require hospitalization.The main study endpoints were the length of stay in hospital and the clinical response.
Detailed Description
Among 136 patients assessed within 12 hours for entry into the study, 109 (69 males) accepted to participate, gave an informed consent and were randomly assigned either to receive every 6 hours the nebulized 0.9% saline (NS) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids). Patients were randomized to receive different saline treatments using a computer-based randomization program. Study solutions, prepared by the local hospital pharmacy, were blinded to participants and investigators. Each treatment was delivered by a nebulizer with continuous flow of oxygen at 6 L/min through a tight-fitting facemask.
The main study endpoints were the length of stay (LOS) in hospital and the clinical response. LOS in hospital was defined as the time between study entry (within 12 hours of admission to the hospital) and the time at which the infant was discharged on the basis of the clinical grounds by the attending physician. Clinical response was determined using daily CSS evaluation; furthermore, the CSS was evaluated every day before and 30 minutes after nebulisation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, 3% Hypertonic Saline Solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.9% saline
Arm Type
Placebo Comparator
Arm Description
patients receive every 6 hours the nebulized 0.9% saline (placebo comparator) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
Arm Title
3% hypertonic saline
Arm Type
No Intervention
Arm Description
Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
Intervention Type
Other
Intervention Name(s)
3% hypertonic saline solution
Intervention Description
Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
Primary Outcome Measure Information:
Title
time of hospitalization
Description
length of stay
Time Frame
six days
Secondary Outcome Measure Information:
Title
Clinical response before and 30 minutes after nebulisation by score
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children aged less than 2 years old
clinical diagnosis of bronchiolitis
Exclusion Criteria:
cardiac or pulmonary diseases
premature birth < 36 weeks of gestational age
previous diagnosis of asthma
an initial oxygen saturation of 85%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Miraglia, MD
Organizational Affiliation
Pediatric Department
Official's Role
Study Director
Facility Information:
Facility Name
Azienda Sanitaria Locale Napoli 2 Nord
City
Pozzuoli
State/Province
Napoli
ZIP/Postal Code
80072
Country
Italy
12. IPD Sharing Statement
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Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis
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