NCT02527798

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 7 Days – 28 Days
• Healthy volunteers: Not accepted

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

Detailed 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 36 weeks post menstrual age. The final study assessment will occur at the time of discharge, early termination or transfer.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Furosemide Cohort 1	furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.
DRUG	Furosemide Cohort 2	furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
DRUG	Furosemide Cohort 3	furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
OTHER	Placebo	Sugar water will be administered in a equivalent volume as drug intervention.

Timeline

• Start date: 2015-11-27
• Primary completion: 2019-10-15
• Completion: 2019-10-15
• First posted: 2015-08-19
• Last updated: 2021-12-28
• Results posted: 2021-12-28

Locations

21 sites across 1 country: United States