Inhaled Furosemide Versus Placebo for Acute Viral Bronchi... | NCT00261937

Studies
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

NCT00261937

Sponsor

Bnai Zion Medical Center

Status

Completed

Last Update Posted

Feb 6, 2013Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Bronchiolitis

Interventions

Inhaled Furosemide vs Placebo (Normal Saline)

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Dec 5, 2005

First Submission Date that Met QC Criteria

Dec 5, 2005

First Posted Date

Dec 6, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2013

Last Update Posted Date

Feb 6, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Inhaled Furosemide vs Placebo (Normal Saline)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical respiratory effects

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Kugelman	Bnai Zion Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion Medical Center and Naharia Galilli Medical Center		Haifa		31048	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18214942	Result	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.

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations