Intravenous sildenafil for the treatment of persistent pulmonary hypertension of the newborn in a resource-limited setting

Abstract

Introduction: Treatment of severe persistent pulmonary hypertension of the newborn (PPHN) is based on the administration of selective pulmonary vasodilators. Inhaled nitric oxide is the only vasodilator therapy approved by the Food and Drug Administration. Non-selective vasodilator such as sildenafil has been the treatment available administered orally in most developing countries to manage newborn with PPHN. The aim of the study was to describe the effects and tolerability of intravenous (IV) sildenafil, as a loading dose of 0.4 mg/kg, followed by a continuous infusion of 1.6 mg/kg for 72 h on the oxygenation index (OI) in neonates with PPHN. Materials and Methods: This was an exploratory observational prospective study. Newborns ≥35 weeks of gestational age, post-natal age ≤72 h, with PPHN and an OI ≥20 were included in the study. Sildenafil was administered intravenously as a loading dose of 0.4 mg/kg, followed by a continuous infusion of 1.6 mg/kg for 72 h. During the sildenafil infusion, monitoring of vital signs and respiratory parameters was performed. The data were analysed with the SPSS v21. Results: Twenty-five infants were included. A significant improvement (P = 0.01) of OI (at admission, median: 25 and interquartile range [IQR] = 8) was observed at the end of the loading dose (3 h) (18 IQR = 4) and at 72 h (7 IQR = 4). No serious adverse effects were observed. Before hospital discharge, seven patients died. Conclusions: IV sildenafil administered, in newborns with PPHN with an IO ≥20, improved oxygenation in most of the patients without serious side effects.