Efficacy and safety of a novel nitric oxide generator for the treatment of neonatal pulmonary hypertension: Experimental and clinical studies

Abstract

Persistent pulmonary hypertension of the newborn (PPHN) is a complex pathology resulting from a failure of the post-natal reduction in pulmonary vascular resistance leading to hypoxemia. The standard therapy is inhaled Nitric Oxide (NO) improving oxygenation but its availability is limited, especially in hospitals with restricted financial resources. We evaluated the efficacy and safety of a new device generating NO (TAS + PLUS), in three experimental piglet models of pulmonary hypertension (PH), and we later tested its application in a pilot study of newborn patients suffering from PPHN.Piglets with experimentally induced PH showed a decrease in pulmonary arterial pressure (PAP) after breathing NO. Both acute and chronic exposure of piglets and rats did not cause any adverse effect in blood gas levels and biological parameters. A pilot study including 32 patients suffering from PPHN showed an increase in oxygen saturation (SatO2) and partial pressure of oxygen in arterial blood (PaO2) leading to a decrease of Oxygenation Index (OI) after compassionate treatment with NO from TAS + PLUS device.The device showed effectiveness and safety both in experimental PH and in the clinical setting. Therefore, it represents an excellent alternative for PPHN management in conditions where commercial NO is unavailable.