Trial Outcomes & Findings for Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis (NCT NCT02469597)

NCT ID: NCT02469597

Last Updated: 2016-08-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: 2 hours after medication adminstration
• Results posted on: 2016-08-12

Participant Flow

Patients were enrolled at a tertiary care, academic children's hospital in the Pediatric Emergency Department from February 2013 to March 2016.

Participant milestones

Measure	Single Dose of Furosemide 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	Placebo 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 Study STARTED	22	24
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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 n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.7 months STANDARD_DEVIATION 5.5 • n=5 Participants	8.1 months STANDARD_DEVIATION 6.8 • n=7 Participants	7.9 months STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours after medication adminstration

Outcome measures

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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
Respiratory Rate	-3.7 Percentage change in respiratory rate Standard Error 5.5	-1.7 Percentage change in respiratory rate Standard Error 5.3

PRIMARY outcome

Timeframe: 4 hours after medication adminstration

Outcome measures

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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
Respiratory Rate	-2.8 Percentage change in respiratory rate Standard Error 6.5	-5.4 Percentage change in respiratory rate Standard Error 6.3

PRIMARY outcome

Timeframe: 2 hours after medication adminstration

Outcome measures

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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
Oxygen Saturation	-0.14 Percentage change in oxygen saturation Standard Error 0.67	0.2 Percentage change in oxygen saturation Standard Error 0.6

PRIMARY outcome

Timeframe: 4 hours after medication adminstration

Outcome measures

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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
Oxygen Saturation	-0.19 Percentage change in oxygen saturation Standard Error 0.58	0.29 Percentage change in oxygen saturation Standard Error 0.84

SECONDARY outcome

Timeframe: Within 72 hours of medication administration

Outcome measures

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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
Patient Needing Endotracheal Intubation	0 participants	0 participants

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay up to 1 week

Outcome measures

Measure	Single Dose of Furosemide n=22 Participants 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	Placebo n=24 Participants 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
Length of Hospital Stay	3.1 Days Standard Error 0.5	3.0 Days Standard Error 0.5

Adverse Events

Single Dose of Furosemide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kristy Williamson

Northwell Health- Cohen Children's Medical Center

Phone: 718-470-7640

Email: kwilliam12@nshs.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place