Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants - Tabular View

Tracking Information

First Received Date ^ICMJE

December 5, 2005

Last Updated Date

December 5, 2005

Start Date ^ICMJE

December 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical respiratory effects

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

1. The duration of hospitalization
2. Time weaned off oxygen
3. Time to full enteral feeding

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

Official Title ^ICMJE

Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bronchiolitis

Intervention ^ICMJE

Drug: Inhaled Furosemide vs Placebo (Normal Saline)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 12 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Amir Kugelman, MD

972-4-8345397

dramir@netvision.net.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00261937

Responsible Party

Study ID Numbers ^ICMJE

67/05

Study Sponsor ^ICMJE

Bnai Zion Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Amir Kugelman

Bnai Zion Medical Center

Information Provided By

Bnai Zion Medical Center

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP