A Randomized, Single-blind, Comparison Trial of Beractant (BeraksurfTM) versus Poractant Alfa (Curosurf®) in the Treatment of Respiratory Distress Syndrome in Preterm Infants

Abstract

Background: Neonatal respiratory distress syndrome (NRDS) affects approximately up to 7% of all term newborns. This study aimed to assess the efficacy and safety of investigational beractant (BeraksurfTM, Tekzima Company) in comparison with poractant alfa (Curosurf®, Chiesi Pharmaceuticals) as surfactant replacement therapy in NRDS. Methods: This trial was a randomized, controlled, single-blind, phase III study of two natural surfactants which was conducted in NICU of Alzahra hospital in Tabriz for 8 months. 220 infants were enrolled in 2 groups to receive either 100 mg/kg BeraksurfTM or 200 mg/kg Curosurf® as an initial dose endotracheally. Additional doses were given if needed. Infants’ gestational age, birth weight, discharge weight and other demographic information were recorded. Efficacy outcomes were changes of fraction of inspired oxygen (FiO2) and the number of infants who reached FiO2 less than 0.3 (treatment success rate) which were compared between both groups with analysis of covariance (ANCOVA). Results: The results showed that the treatment success rate was 92% and 72% in BeraksurfTM and Curosurf® groups, respectively (Pvalue< 0.001). In addition, no difference was observed in the efficacy of these two treatments in terms of binary outcomes and incidence of complications such as mortality. Conclusion: The result analysis of current study implies BeraksurfTM has same beneficial impact on clinical management of RDS as Curosurf® among infants below 32 weeks. However, larger studies are needed to evaluate further efficacy and safety outcomes of this surfactant in comparison with the reference products in other subgroups.