Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension - Trial PACTR201902691230243

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Summary

Persistent pulmonary hypertension is a clinical syndrome characterized by suboptimal oxygenation as a result of sustained elevation in pulmonary vascular resistance after birth. In PPHN, there is vasoconstriction of the pulmonary vessels that may occur secondary to one of several reasons (e.g. prolonged hypoxemia, perinatal ischemic injury or an underlying lung parenchymal disease process). When the pulmonary vascular resistance exceeds the systemic vascular resistance, a right to left shunt of deoxygenated blood occurs through the persistent foramen ovale or the ductus arteriosus resulting in hypoxemia. The diagnosis of PPHN can be often difficult to make, especially in clinical setting in which pediatric echocardiography is not readily available. It should be considered basically in evaluating the cyanotic newborn. Oxygen saturation, chest radiograph, electrocardiography and echocardiography are all important in the diagnosis.There is a wide range of severity in pulmonary hypertension, a Doppler-estimated pulmonary artery systolic pressure of 40 mmHg has been assumed as a cutoff value for mild pulmonary hypertension. Severe pulmonary hypertension is diagnosed when pulmonary artery pressure exceeds two thirds the systemic blood pressure. Current guidelines states that lines of treatment for persistent pulmonary hypertension of the newborn include inhaled nitric oxide (INO) along with high frequency ventilation, surfactant and supportive measures including sedation and blood pressure support remain the mainstays in PPHN management. Extracorporeal membrane oxygenation (is an option when these measures fail. Oral/IV sildenafil, IV milrinone and inhaled prostaglandin inhibitors 2 (PGI2) may have a synergistic effect with INO and are being used more frequently. The aim of this work is to compare the efficacy of combined IV milrinone plus oral seldinafil to IV milrinone alone or oral sildenafil alone in the management of neonatal persistent pulmonary hypertension.

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