Oral Sildenafil in Persistent Pulmonary Hypertension of the Newborn

Abstract

Purpose: To evaluate the effect of oral sildenafil therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN) Methods: We conducted a retrospective review of 32 neonates ≥35 weeks' gestation and fraction of inspired oxygen (FiO 2 ) 1.0 with PPHN. The first dose (0.5 mg/kg) of oral sildenafil was started and 1 mg/kg was given every 6 hour thereafter. Mean airway pressure (MAP), FiO 2 , oxygenation index (OI), mean arterial blood pressure (MBP) were documented before and 6, 12, 24, and 48 hours after sildenafil. For adverse effects, gastrointestinal symptoms, brain ultrasound, funduscopy and auditory brainstem response results were evaluated. Results:The underlying diseases of PPHN (n=32) were meconium aspiration syndrome (n=9), respiratory distress syndrome (n=8), pneumonia (n=3), and idiopathic (n=12). Thirty-one neonates survived; 3 neonates were transferred for inhaled nitric oxide (iNO) and all of them survived. In 28 infants, FiO 2 and OI improved significantly by 6 hours and MAP improved significantly by 48 hours after initiation of sildenafil. There were no clinically significant adverse effects of sildenafil. Conclusion: Sildenafil may be an effective and safe agent for near-term and term neonates with PPHN, providing significant improvement in oxygenation, and thus may be especially useful in the treatment of PPHN in hospitals without iNO.

Use of off-label compounded oral sildenafil in the management of persistent pulmonary hypertension of the newborn: A case report

“…Prevalence of persistent pulmonary hypertension of the newborn is estimated to be 1.9 per 1000 births in the United States 5 while a prevalence rate of 1.1% was reported in South Africa. 6 Meconium aspiration syndrome is one of the major causes of PPHN, 7 it leads to obstruction of the airway which results in atelectasis and lung collapse. 8 Treatment of PPHN includes the use of vasodilators like inhaled nitric oxide, prostaglandins and sildenafil.…”

“…Inhaled nitric oxide is not readily available in resource limited countries such as ours, whereas sildenafil is available and has been reported to be effective and safe when given either by intravenous or oral route. 7 There is dearth of literature from Nigeria on PPHN and the use of compounded oral sildenafil. This case report is important to create awareness among physicians managing newborns especially in developing countries who may encounter challenges managing newborns with persistent pulmonary hypertension due to non-availability of drugs like inhaled nitric oxide.…”