Effectiveness of Bosentan VS Sildenafil for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Abstract

Background: Persistent pulmonary hypertension of the newborn (PPHN) is a serious disease among newborns. Pulmonary vasodilators such as Sildenafil, Bosentan and Milrinone are important treatment modalities to treat persistent pulmonary hypertension of the newborn, especially in resource limited centers where inhaled nitric oxide is not available. Objective: To assess and compare the effectiveness of Bosentan and Sildenafil in persistent pulmonary hypertension of the newborn. Method: This randomized controlled trial was done in the NICU, ICMH, Matuail, Dhaka during July 2017 to July 2019. Following echocardiographic diagnosis, a total of 76 patients were randomly assigned into group A and group B (by lottery). Bosentan was given to group A (1mg/kg/body wt) 12 hourly for 7 days and Sildenafil was given to group B (2mg/kg/body wt.) 8 hourly for 7 days via oro-gastric tube/orally. Then heart rate, respiratory rate, cyanotic changes, SPO2 was recorded every day for 7 days and finally on the 8th day echocardiographic findings were obtained. Effects of two groups were compared. Results: The age of presentation of persistent pulmonary hypertension of newborn was < 24 hours and male newborns were predominant in both groups. Almost 100 % newborns had cyanosis, tachypnea and SPO2 <80% on admission. After intervention for 7 days in both groups no newborn had cyanosis or tachypnea. The mean pulmonary artery systolic pressure (PASP) on echocardiography before and after intervention was found (53.16 ± 9.263 and 35.55 ± 6.41) mm of Hg in group A. The mean PASP on echocardiography before and after intervention was found (53.24 ±11.012 and 35.45 ± 7.43) mm of Hg respectively in group B. In both groups the mean PASP was decreased significantly after intervention. But while comparing the PASP between two groups, there was no significant (p>0.05) difference. The mean length of stay in hospital was 13.05 ± 2.96 days for group A and 13.34 ± 2.86 days for group B. The mean length of ......