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 to evaluate 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