The most common serious disease associated with premature birth is bronchopulmonary dysplasia (BPD). More than 60,000 infants are born ≤29 weeks gestational age each year in the United States, and nearly 40% of those develop BPD.
Premature infants with BPD are challenging to treat and frequently suffer from multiple morbidities such as pulmonary hypertension, prolonged hospitalization, and life-long neurodevelopmental problems. Because the consequences of BPD can be catastrophic, neonatologists frequently use diuretics such as furosemide and bumetanide 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 and bumetanide in premature infants, however, is limited. This is due, in part, to concerns about exposing premature infants to the risks of prospective drug studies. Fortunately, retrospective observational studies carry no risk for participants.
We will conduct an observational, retrospective study using medical records from approximately 700 extremely-low-birth-weight infants admitted to neonatal intensive care units. The data analyzed will provide valuable safety information for the use of these drugs in premature infants and will facilitate the design of future clinical trials.
Report submitted to FDA
Kathleen A. Nevill, MD, MD, Children's Mercy Hospital Kansas City
- Comparative effectiveness of 3 surfactant preparations in premature infants October 1, 2013 Journal of Pediatrics • October 2013. Trembath A, Hornik CP, Clark R, Smith PB, Daniels J, Laughon M; Best Pharmaceuticals for Children Act—Pediatric Trials Network. To compare effectiveness of 3 surfactant preparations (beractant, calfactant, and poractant alfa) in premature infants for preventing 3 outcomes: (1) air leak syndromes; (2) death; and (3) bronchopulmonary dysplasia (BPD) or death (composite ...