IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN)

To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Inclusion Criteria:

• Babies < 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia
• Oxygenation index >15 and < 60

Exclusion Criteria:

• Congenital anomaly
• Large left to right intracardiac or ductal shunt
• Already on inhaled nitric oxide