Back to resultsInhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Inhaled Furosemide vs Placebo (Normal Saline)
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility Criteria
Inclusion Criteria: Age: 0-12 months. Infants who are otherwise healthy Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately. Parents signed a written informed consent. Exclusion Criteria: • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.
Sites / Locations
- Bnai Zion Medical Center and Naharia Galilli Medical Center
Outcomes
Primary Outcome Measures
Clinical respiratory effects
Secondary Outcome Measures
1. The duration of hospitalization
2. Time weaned off oxygen
3. Time to full enteral feeding
Full Information
NCT ID
NCT00261937
First Posted
December 5, 2005
Last Updated
February 5, 2013
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00261937
Brief Title
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
Official Title
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
5. Study Description
Brief Summary
We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled Furosemide vs Placebo (Normal Saline)
Primary Outcome Measure Information:
Title
Clinical respiratory effects
Secondary Outcome Measure Information:
Title
1. The duration of hospitalization
Title
2. Time weaned off oxygen
Title
3. Time to full enteral feeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 0-12 months.
Infants who are otherwise healthy
Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately.
Parents signed a written informed consent.
Exclusion Criteria:
• Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Kugelman
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center and Naharia Galilli Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
18214942
Citation
Bar A, Srugo I, Amirav I, Tzverling C, Naftali G, Kugelman A. Inhaled furosemide in hospitalized infants with viral bronchiolitis: a randomized, double-blind, placebo-controlled pilot study. Pediatr Pulmonol. 2008 Mar;43(3):261-7. doi: 10.1002/ppul.20765.
Results Reference
result
Learn more about this trial
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
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