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Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02469597
First Posted: June 11, 2015
Last Update Posted: August 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sandeep Gangadharan, Northwell Health
  Purpose
The purpose of this study is to assess if administration of an early single dose of a diuretic (furosemide) to children with moderate to severe bronchiolitis can reduce extravascular lung water in an effort to reduce respiratory rate, retractions, intubations, and length of stay.

Condition Intervention Phase
Bronchiolitis Drug: Furosemide Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Sandeep Gangadharan, Northwell Health:

Primary Outcome Measures:
  • Respiratory Rate [ Time Frame: 2 hours after medication adminstration ]
  • Respiratory Rate [ Time Frame: 4 hours after medication adminstration ]
  • Oxygen Saturation [ Time Frame: 2 hours after medication adminstration ]
  • Oxygen Saturation [ Time Frame: 4 hours after medication adminstration ]

Secondary Outcome Measures:
  • Patient Needing Endotracheal Intubation [ Time Frame: Within 72 hours of medication administration ]
  • Length of Hospital Stay [ Time Frame: Participants will be followed for the duration of hospital stay up to 1 week ]

Enrollment: 46
Study Start Date: October 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Dose of Furosemide
Furosemide 1 dose
Drug: Furosemide
1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose
Other Name: Lasix
Placebo Comparator: Placebo
Normal saline 1 dose
Drug: Placebo
0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Acute Bronchiolitis
  • Admission required per Emergency Department Physician

Exclusion Criteria:

  • No legal guardian present
  • Sulfa allergy
  • Patient currently on existing diuretic therapy
  • Tracheostomy
  • Mild respiratory distress (not requiring admission)
  • Hypotension / Hemodynamic Instability (defined by age specific criteria at time of intervention)
  • Supplemental Oxygen at home
  • History of Dialysis / Renal Disease
  • Those enrolled in another drug interventional study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469597


Locations
United States, New York
Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Sandeep Gangadharan, MD Northwell Health
  More Information

Additional Information:
Publications:

Responsible Party: Sandeep Gangadharan, Principal Investigator, MD, Northwell Health
ClinicalTrials.gov Identifier: NCT02469597     History of Changes
Other Study ID Numbers: 12-260B
First Submitted: May 24, 2015
First Posted: June 11, 2015
Results First Submitted: June 30, 2016
Results First Posted: August 12, 2016
Last Update Posted: August 12, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action