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

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ClinicalTrials.gov Identifier: NCT02469597
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Sandeep Gangadharan, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bronchiolitis
Interventions Drug: Furosemide
Drug: Placebo
Enrollment 46
Recruitment Details Patients were enrolled at a tertiary care, academic children’s hospital in the Pediatric Emergency Department from February 2013 to March 2016.
Pre-assignment Details  
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description

Furosemide 1 dose

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

Normal saline 1 dose

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

Period Title: Overall Study
Started 22 24
Completed 22 24
Not Completed 0 0
Arm/Group Title Single Dose of Furosemide Placebo Total
Hide Arm/Group Description

Furosemide 1 dose

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

Normal saline 1 dose

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

Total of all reporting groups
Overall Number of Baseline Participants 22 24 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
<=18 years
22
 100.0%
24
 100.0%
46
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 22 participants 24 participants 46 participants
7.7  (5.5) 8.1  (6.8) 7.9  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Female
8
  36.4%
9
  37.5%
17
  37.0%
Male
14
  63.6%
15
  62.5%
29
  63.0%
1.Primary Outcome
Title Respiratory Rate
Hide Description [Not Specified]
Time Frame 2 hours after medication adminstration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description:

Furosemide 1 dose

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

Normal saline 1 dose

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

Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage change in respiratory rate
-3.7  (5.5) -1.7  (5.3)
2.Primary Outcome
Title Respiratory Rate
Hide Description [Not Specified]
Time Frame 4 hours after medication adminstration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description:

Furosemide 1 dose

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

Normal saline 1 dose

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

Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage change in respiratory rate
-2.8  (6.5) -5.4  (6.3)
3.Primary Outcome
Title Oxygen Saturation
Hide Description [Not Specified]
Time Frame 2 hours after medication adminstration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description:

Furosemide 1 dose

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

Normal saline 1 dose

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

Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage change in oxygen saturation
-0.14  (0.67) 0.2  (0.6)
4.Primary Outcome
Title Oxygen Saturation
Hide Description [Not Specified]
Time Frame 4 hours after medication adminstration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description:

Furosemide 1 dose

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

Normal saline 1 dose

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

Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage change in oxygen saturation
-0.19  (0.58) 0.29  (0.84)
5.Secondary Outcome
Title Patient Needing Endotracheal Intubation
Hide Description [Not Specified]
Time Frame Within 72 hours of medication administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description:

Furosemide 1 dose

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

Normal saline 1 dose

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

Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: participants
0 0
6.Secondary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description:

Furosemide 1 dose

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

Normal saline 1 dose

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

Overall Number of Participants Analyzed 22 24
Least Squares Mean (Standard Error)
Unit of Measure: Days
3.1  (0.5) 3.0  (0.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Dose of Furosemide Placebo
Hide Arm/Group Description

Furosemide 1 dose

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

Normal saline 1 dose

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

All-Cause Mortality
Single Dose of Furosemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Dose of Furosemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Dose of Furosemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/24 (0.00%) 
The trial was ended early due to recruitment difficulties.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kristy Williamson
Organization: Northwell Health- Cohen Children's Medical Center
Phone: 718-470-7640
EMail: kwilliam12@nshs.edu
Publications:
Layout table for additonal information
Responsible Party: Sandeep Gangadharan, 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