Study of the Effect of Sildenafil on Improving Chronic Lung Disease of neonates

Abstract

Bronchopulmonary dysplasia is a side effect in preterm infants with an incidence of 5-68%, which can be increased significantly by decreasing gestational age and birth weight. Due to the evidences of a positive effect of sildenafil in the control and treatment of chronic lung diseases in infants such as bronchopulmonary dysplasia and also due to disagreement on the side effects of sildenafil in previous studies, this study aims to evaluate the role of sildenafil in the treatment of chronic lung diseases in infants. Methods and Materials: This study was performed as a placebo-controlled clinical trial and patients were randomly divided into control and intervention groups. Sildenafil was prescribed in 50 mg tablet at a dose of 2 mg per kg body weight every 8 hours in the intervention group and the placebo was prescribed in the same form and with the same characteristics for patients in the control group. After a 10-day treatment period, variables such as oxygen demand (FiO2), type of respiratory support and related requirements, pulmonary artery pressure changes (measured by echocardiography), duration of hospitalization and systemic pressure changes in patients in the intervention group and the control group was measured. Results: In this study, 40 patients were studied and two patients were excluded from the study due to death and malnutrition. 19 patients were in the control group (50%) and 19 patients (50%) were in the intervention group. The duration of hospitalization in the control group was 35.26 55 13.55 days and, in the intervention, group was 21 ± 36.9 days, which significantly decreased in the intervention group (P value = 0.006). Patients in the control group from approximately 11th day of hospitalization (47.11 ± 19.9) and in the intervention group from approximately 8th day of hospitalization (21.8 ± 84.3), respiratory support with the positive pressure changed to respiratory support in the form of oxygen free flow. It was found that during this period, the intervention group had a significant decrease (P value = 0.001). The trend of FiO2 change was not significantly different between the two groups (P value = 0.710). No severe systolic or diastolic hypotension was observed in any of the patients. The number of patients whose pulmonary pressure improved during treatment was significantly higher in the intervention group than the control group (21.1%), 4 in the control group compared to 13.48% in the intervention group, (P value= 0.003).