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

Phase 2 Completed 82 enrolled University of North Carolina, Chapel Hill Duke University · collab Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab The Emmes Company, LLC · collab

RandomizedParallel-groupQuadruple-blindOther

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

Timeline

Start: 2015-11-27
Primary completion: 2019-10-15
Completion: 2019-10-15

Publications

Greenberg RG, Lang J, Smith PB, Shekhawat P, Courtney SE, Hudak ML, Moya F, Iyengar A, Eldemerdash A, Bloom B, Go M, Hanna M, Rhein L, Aliaga S, Lewis T, Febre A, Kiefer AS, Bhatt-Mehta V, Khoury JA, Selewski D, Anand R, Martz K, Payne EH, Zimmerman KO, Benjamin DK Jr, Laughon M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Furosemide Safety in Preterm Infants at Risk for Bronchopulmonary Dysplasia: A Randomized Clinical Trial. J Pediatr. 2025 Aug;283:114629. doi: 10.1016/j.jpeds.2025.114629. Epub 2025 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Furosemide	Other / unclassified	1 mg/kg	Intravenous
Subject	Furosemide	Other / unclassified	2 mg/kg	Intravenous
Subject	Furosemide	Other / unclassified	4 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications