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NCT00261937 Clinical Trial

Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

Bronchiolitis Clinical Trial

Official title:
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00261937
Other study ID # 67/05
Secondary ID
Status Completed
Phase Phase 1
First received December 5, 2005
Last updated February 5, 2013
Start date December 2005
Est. completion date April 2006

Study information
Verified date December 2005
Source Bnai Zion Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled Furosemide vs Placebo (Normal Saline)

Locations
Country Name City State
Israel Bnai Zion Medical Center and Naharia Galilli Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical respiratory effects
Secondary 1. The duration of hospitalization
Secondary 2. Time weaned off oxygen
Secondary 3. Time to full enteral feeding
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