About the Study

Bronchopulmonary Dysplasia (BPD): A study of Sildenafil in premature babies to evaluate its safety and ability to prevent pulmonary hypertension

This study is for infants: • Born prematurely • Less than 1 year of age • Have a form of lung disease called bronchopulmonary dysplasia (BPD), that may develop an additional problem called pulmonary hypertension.This study will learn more about the safety of a drug called sildenafil which is an approved drug available by prescription for use in adult patients with pulmonary hypertension, but is not approved for use in patients less than 1 year of age. Researchers want to learn more about sildenafil side effects and how well it works to prevent long-term problems of BPD, and the best amount (dose) to give in premature babies with BPD. Pulmonary hypertension may worsen the lung disease, and are currently no medicines available to prevent it. Researchers want to find new ways to prevent long-term problems such as pulmonary hypertension in babies with BPD because infants with those conditions are at a higher risk of dying.

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Full Study Name: SILDI-SAFE