Safety of Sildenafil in Premature Infants

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, 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.

 

OVERVIEW

Status:
Enrolling

ClinicalTrials.gov Identifier:
NCT03142568

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

NEWS

  • Sildenafil safety study achieves major milestone August 28, 2019 The Pediatric Trials Network (PTN) recently enrolled the fortieth infant in the Safety of Sildenafil in Premature Infants study. This is a major study milestone, as it rounds out the first cohort (or group of study participants). The study aims to assess the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia (BPD) and ...
  • Sildenafil safety studied for premature infants with bronchopulmonary dysplasia January 18, 2018 The Pediatric Trials Network (PTN), with support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is conducting an interventional study to examine the safety and efficacy of sildenafil in treating bronchopulmonary dysplasia (BPD) in premature infants. BPD is a common chronic lung disease that can affect premature newborns, often leading to ...
  • A busy week for the PTN sildenafil trial February 26, 2013 The week of February 18–22 saw many milestones in the PTN sildenafil trial. On Tuesday, the first investigator’s meeting was held. By Wednesday, the trial’s first two sites had been activated — one at the Medical University of South Carolina Children’s Hospital (MUSC) and the other at the University of North Carolina–Chapel Hill. And, on ...