Phase 2
Completed N=82
Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Source: ClinicalTrials.gov NCT02527798 ↗Enrolled (actual)
82
Serious AEs
15.0%
Results posted
Dec 2021
Primary outcomePrimary: Safety as Determined by Adverse Events — 123; 29; 100; 49 Events
Summary
This study will describe the safety of furosemide in premature infants at risk of bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics (PK) of furosemide. Funding Source - FDA OOPD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Determined by Adverse Events |
123; 29; 100; 49; 293 | — |
| SECONDARY Moderate-Severe BPD or Death Risk Throughout Weekly Treatment |
57.9; 52.8; 66.7; 70.9; 62.3; 55.4 | — |
| SECONDARY Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined |
17; 22; 6; 6 | — |
| SECONDARY Clearance |
16.3; 21.8; 18 | — |
| SECONDARY Volume of Distribution |
236.7; 242.8; 242.8 | — |
| SECONDARY Half-life |
9.8; 7.3; 8.8 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve |
2165; 6016; 4639 | — |
Eligibility Criteria
Inclusion Criteria
- Receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or mechanical ventilation (high frequency or conventional)
- 1.7 mg/dL 50 mg/dL 10 mg/dL < 24 hours prior to first study dose
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Data sourced from ClinicalTrials.gov (NCT02527798). 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. Informational only — not medical advice.