Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study

• Parent(s) or legal guardian provided consent for the subject to participate

• Weight at least 2 kg at Screening

• Gestational age of ≥34 weeks and ≤14 days old at Screening

• Diagnosis of PPHN, which was either idiopathic in nature or associated with the following: meconium aspiration syndrome, pneumonia, respiratory distress syndrome, sepsis, birth hypoxia, perinatal encephalopathy, or unilateral congenital diaphragmatic hernia

• Currently requiring ventilator support

• Two consecutive oxygenation index (OI) of 15 or greater separated by at least 30 minutes, after receiving iNO for at least 3 hours

• Echocardiographic (ECHO) evidence of pulmonary hypertension with elevated right ventricle pressure

• Dedicated venous access for the administration of study drug (central line or peripherally inserted central venous catheter)