Treatment of persistent pulmonary hypertension of the newborn with intravenous sildenafil

Abstract

Introduction. Persistent pulmonary hypertension of the newborn (PPHN) is a serious disease with high mortality.

The objective of the study was to assess the tolerance and adverse effects in neonates with HPPRN treated with intravenous sildenafil.

Methodology: Observational exploratory of followup of a cohort. Neonates with gestational age ≥ 35 weeks, ≤ 72 hours of postnatal age, were enrolled in the study if they met the following criteria: a clinical and echocardiography diagnosis of PPHN, oxygenation index (OI) ≥ 20 and parental informed consent .Sildenafil citrate (12,5 ml of solution equivalent to 10 mg of sildenafil) was administrate at a loading dose of 0.4 mg/kg to be passed in 3 h, followed by continuous infusion of 1.6mg/kg for 72 hs. Variables: anthropometric and perinatal data, main diagnosis, SNAP II and monitoring of OI, SpO2, PaO2, Systemic blood pressure, vital signs, and adverse effects attributable to sildenfil at 3, 24,48,72 h of the infusion. The analysis was performed with SPSS. The protocol was approved by the institutional ethics committee.

Results: 25 neonates were admitted, with gestational age of 36.8 ± 2 and birth weight of 3313.8 ± 387 g. The OI at admission had a median of 25 (IQR 20- 28), the SNAP II severity score was 44.9 ± 11.7. At 24 hours of infusion, a 60% decrease in IO was observed, PaO2 and systemic blood pressure rose and Sp02 decreased. Two patients did not respond. 7/25 died in the neonatal period, not attributable to sildenafil.

Conclusions: intravenous sildenafil produced a sustained decrease in pulmonary pressure without serious adverse effects.