NCT00261937

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

February 6, 2013

Status Verified

December 1, 2005

First QC Date

December 5, 2005

Last Update Submit

February 5, 2013

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • Clinical respiratory effects

Secondary Outcomes (3)

  • 1. The duration of hospitalization

  • 2. Time weaned off oxygen

  • 3. Time to full enteral feeding

Interventions

Inhaled Furosemide vs Placebo (Normal Saline)DRUG

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center and Naharia Galilli Medical Center

Haifa, 31048, Israel

Location

Related 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.

    PMID: 18214942RESULT

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Amir Kugelman

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 5, 2005

First Posted

December 6, 2005

Study Start

December 1, 2005

Study Completion

April 1, 2006

Last Updated

February 6, 2013

Record last verified: 2005-12

Locations

IL(1)