Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia (BPD) and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil.
Summary
BPD is a common chronic lung disease that can affect premature newborns, often leading to life-long medical problems, prolonged hospitalization, and even death. Approximately 17,500 U.S. infants develop BPD each year.
Sildenafil, which is approved for the treatment of pulmonary hypertension in adults and children (ages 1-17), may help improve lung development and is increasingly being used off-label in premature infants with BPD. However, the efficacy and safety of sildenafil in premature infants at risk for BPD is currently unknown.
Safety will be assessed following initial study-specific procedure (e.g., screening blood draws, dosing through 14 days post last study dose) and it will be assessed by frequency and incidence of adverse events and serious adverse events. The study team aims to enroll up to 120 participants.
Publications
- Safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia: Rationale and methods of a phase II randomized trialContemporary Clinical Trials Communications • December 2022 Access article on PubMed. Lang JE, Hornik CD, Martz K, Jacangelo J, Anand R, Greenberg R, Hornik C, Zimmerman K, Smith PB, Benjamin DK, Laughon M Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to many complications. BPD is the ...
OVERVIEW
Status:
Analysis
ClinicalTrials.gov Identifier:
NCT03142568
Principal Investigator:
Matthew Laughon, MD, MPH
University of North Carolina
Chapel Hill, NC