#3: Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia

Human Clinical Trial-Confidential The Best Pharmaceuticals for Children Act (BPCA) mandates the National Institutes of Health (NIH) to prioritize therapeutic areas in critical need for pediatric labeling, sponsor pediatric clinical trials, and submit these data to FDA for consideration for labeling changes. This study will be conducted in accordance with Section 409l of the Public Health Service Act; as such, the results from this research may be submitted to the FDA for review and use in negotiated labeling changes. This research study is contractually supported by the NICHD. The NICHD awarded a contract to the Duke Clinical Research Institute (DCRI) to establish a Pediatric Trials Network (PTN) in order to facilitate trial design for studies supported by NIH. A separate contract is awarded to The EMMES Corporation to serve as the BPCA Data Coordinating Center. Neonatologists commonly use diuretics, with furosemide being the most common by far (93% of diuretic use), in premature infants. The majority of drugs used in premature infants have undergone insufficient study to receive FDA labeling, including diuretics. The primary objective of this study is to describe the safety of furosemide in premature infants at risk of Bronchopulmonary dysplasia (BPD). The secondary objective is to evaluate the preliminary effectiveness and pharmacokinetics (PK) of furosemide. This is a Multi-center, randomized, placebo-controlled, dose escalating, double masked, safety study. Approximately 30 sites throughout the US, recruiting 120 study participants. The study will last up to 35 days (28 days of study drug plus 7 days of safety monitoring). Information about hospitalization will be collected at 36 weeks post menstrual age and/or at discharge. At the University of Kentucky, premature infants (inpatient in neonatal intensive care units)