Pragmatic Research on Diuretic Management in Early BPD Pilot

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 17, 2023

Primary Completion Date

July 10, 2025

Study Completion Date

December 31, 2025

Conditions
Bronchopulmonary Dysplasia
Interventions
DRUG

Furosemide (plus potassium chloride)

Furosemide is a loop diuretic that inhibits the reabsorption of sodium and chloride in the proximal and distal tubules as well as the loop of Henle. Participants will receive 2 mg/kg enteral furosemide daily during treatment periods when they receive study drug. To prevent hypokalemia and hypochloremia associated with furosemide use, participants will also receive 1 mg/kg of potassium chloride enterally twice per day when receiving furosemide. Each patient will have 8 days of total exposure to furosemide over the 16-day N-of-1 trial.

DRUG

Placebo (plus placebo electrolyte solution)

During treatment periods when participants receive placebo, they will receive a volume of sterile water equivalent to the study drug dose. Participants will also receive a placebo electrolyte solution equivalent to the volume of potassium chloride that would be given.

Trial Locations (4)

27705

RTI International, Durham

30303

Emory University, Atlanta

44106

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
collaborator

Rainbow Babies and Children's Hospital

OTHER

collaborator

Emory University

OTHER

collaborator

RTI International

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT05898022 - Pragmatic Research on Diuretic Management in Early BPD Pilot | Biotech Hunter | Biotech Hunter