SILDI-SAFE: Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia

Abstract SILDI-SAFE NHLBI-2019-SIL Sildenafil is approved by the FDA for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening. The FDA does not recommend using sildenafil for pulmonary hypertension in children 1 to 17 years of age. Recommendations about sildenafil use in neonates and infants do not exist. Differences in the cardiopulmonary pathophysiology targeted to neonates and infants suggest that sildenafil may be beneficial in this population. As a result, pharmacokinetic (PK) and safety studies of sildenafil in neonates and infants have been or are currently being conducted under the Best Pharmaceuticals in Children’s Act by the National Institute of Child Health and Human Development (NICHD)-funded Pediatric Trials Network (PTN).2 The present study, supported by the National Heart Lung and Blood Institute (NHLBI), will generate additional safety, PK, and preliminary effectiveness data on sildenafil in a subpopulation of infants with severe bronchopulmonary dysplasia (BPD).