Phase 2
N=46
Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis
Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT02469597 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Respiratory Rate — -3.7; -1.7 Percentage change in respiratory rate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Furosemide (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Rate |
-2.8; -5.4 | — |
| PRIMARY Respiratory Rate |
-2.8; -5.4 | — |
| PRIMARY Oxygen Saturation |
-0.19; 0.29 | — |
| PRIMARY Oxygen Saturation |
-0.19; 0.29 | — |
| SECONDARY Patient Needing Endotracheal Intubation |
0; 0 | — |
| SECONDARY Length of Hospital Stay |
3.1; 3.0 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02469597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.