A Comparison of the Effect of Beractant (Beracsurf) and Proctant Alpha (Curosurf) in Neonatal Respiratory Distress: A Randomized Controlled Trial.

Abstract

Background: Surfactant treatment has revolutionized the management of respiratory distress syndrome (RDS) in preterm infants. The present study compared the effectiveness and adverse effects of two natural surfactants, Beracsurf and Curosurf, in premature infants with RDS who required surfactant administration.

Methods: Eighty-four newborns were enrolled in this double-blind randomized controlled trial study, which was conducted in Shiraz, Iran, from 2021 to 2022. The study included all preterm neonates with RDS, who required intubation for stabilization, were on continuous positive airway pressure (CPAP), required oxygen of more than 30% to maintain saturation 90-95%, or had CPAP failure. Using a simple random allocation method, the participants were randomly assigned to receive either Beractant as the case group or Proctant Alpha as the control group. The study assessed outcomes such as hospital length, number of surfactant administration, duration of respiratory support, complications, and mortality in both groups. Data were analyzed using SPSS software and applying independent t tests, Mann-Whitney tests, and Chi square tests.

Results: Eighty-four neonates were enrolled in the study, with 37 in the control group and 47 in the case group. The duration of hospital stay in the control group was 18.07±13.04 days, while it was 23.59±14.03 days in the intervention group (P=0.07). There were no differences between the two groups in terms of the fraction of inspired oxygen (FIO₂) (P=0.46), and complications (P=0.82). However, the intubation period in the Curosurf group was significantly lower (P=0.03). The mortality rate in the Curosurf group was 24.3% (95% CI=10.5%-38.1%); while in the Beracsurf group, it was 10.6% (95% CI=1.8%-19.5%) (P=0.09).

Conclusion: Beracsurf had comparable efficacy to Curosurf and could be considered a viable alternative.Trial Registration Number: IRCT20120126008827N3.