Diuretic Safety in Premature Infants at Risk of Bronchopulmonary Dysplasia

Assessing the safety and preliminary effectiveness of furosemide, which is often used to prevent bronchopulmonary dysplasia, in premature infants.

Summary

More than 60,000 infants are born ≤29 weeks gestational age each year in the United States, and nearly 40% of those develop bronchopulmonary dysplasia (BPD). Because the consequences of BPD can be catastrophic, neonatologists frequently use diuretics such as furosemide to reduce pulmonary edema, improve pulmonary mechanics, minimize exposure to mechanical ventilation, and, ultimately, to prevent BPD. The understanding of the safety profile of furosemide in premature infants, however, is limited.

The PTN is conducting a phase 2, randomized, multicenter, placebo-controlled, dose-escalating, double-masked safety study is evaluating the safety and preliminary effectiveness of furosemide in premature infants at risk of BPD. Approximately 120 infants will be enrolled at ~30 sites. Total duration of study participation is 35 days—28 days of treatment and 7 days of safety monitoring.

Publications

Comparative effectiveness of 3 surfactant preparations in premature infants.
Trembath A, Hornik CP, Clark R, Smith PB, Daniels J, Laughon M; Best Pharmaceuticals for Children Act—Pediatric Trials Network.
Journal of Pediatrics • October 2013, volume 163, issue 4, pages 955-960.
PMCID: PMC3779477 [Free PMC article]

OVERVIEW

Status:
Enrolling

ClinicalTrials.gov identifier:
NCT02527798

Principal Investigators:
Matthew Laughon, MD, MPH
University of North Carolina
Chapel Hill, NC

P. Brian Smith, MD, MPH, MHS
Duke Health, Durham, NC

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