Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchopulmonary Dysplasia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Younger than 28 years
- Gender
- Both males and females
Description
Infants will receive a placebo or furosemide for 28 days. Blood samples will be collected for pharmacokinetic analysis.Premature infants will be randomized to receive placebo or furosemide in a dose escalating approach. Follow up information will be collected up to 7 days after the last dose and at ...
Infants will receive a placebo or furosemide for 28 days. Blood samples will be collected for pharmacokinetic analysis.Premature infants will be randomized to receive placebo or furosemide in a dose escalating approach. Follow up information will be collected up to 7 days after the last dose and at 36 weeks post menstrual age. The final study assessment will occur at the time of discharge, early termination or transfer.
Tracking Information
- NCT #
- NCT02527798
- Collaborators
- Duke University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- The Emmes Company, LLC
- Investigators
- Study Chair: Jason E Lang, MD, MPH Duke University
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