Comparison of the Effectiveness of Beraksurf and Curosurf Exogenous Surfactants in the Treatment of Respiratory Distress Syndrome in Preterm Neonates: A Double-blind Randomized Study in the West of Iran

Abstract

Background: To date, few studies have compared the effectiveness of exogenous surfactant therapy with Curosurf and Beraksurf in the treatment of respiratory distress syndrome (RDS) in preterm neonates. Objective: Since surfactant has a significant impact on the treatment of neonates with RDS, this study was conducted to introduce a more effective method for treating preterm neonates with RDS. Methods: The present clinical trial was conducted on 140 preterm neonates with RDS in the NICU department of two specialized university hospitals in Hamadan, western Iran. In one group, we used the Iranian-made surfactant Beraksurf, and in another group, we used the Italian-made surfactant Curosurf. In the end, the checklist for the two groups was completed. Data analysis was performed using SPSS version 22, and a significance level of 5% was considered for all tests. Results: The comparison of the frequency distribution of maternal corticosteroid administration, response to treatment and need for re-intubation, associated disorders, and mortality among neonates of the two groups of Beracsurf and Curosurf surfactant did not show a significant difference (p=0.962, 0.763, 0.725 and 0.149, respectively). Further, the comparison of the mean number of days requiring respiratory support, days free from respiratory support, and hospitalization days among neonates of the two groups of Beracsurf and Curosurf surfactant injection did not show a significant difference (p=0.910, 0.725, and 0.898, respectively). Additionally, the comparison of the time of initiation of feeding and the time of reaching maximum feeding among neonates of the two groups of Beracsurf and Curosurf surfactant injection also did not show significant differences (p=0.881 and 0.903, respectively). Conclusion: Based on the fact that Beracsurf and Curosurf surfactants did not show significant differences in the treatment outcomes of RDS in preterm neonates, it is suggested that the Iranianmade surfactant, Beracsurf, should be used for the treatment of these neonates due to its cost-effectiveness and availability compared to Curosurf.