Poractant alfa versus beractant in the treatment of preterm infants with RDS: a randomized trial

The biochemical abnormality underlying the onset of respiratory distress syndrome (RDS) is insufficient production of surfactant, which leads to poor compliance of lungs, inadequate gas exchange, and need for high ventilatory pressures. Surfactant replacement therapy improves lung function and reduces morbidity and mortality in newborns with or at risk for RDS. Surfactant is mainly composed of dipalmitoylphosphatidylcholine (DPPC) and surfactant proteins (SPs) and contains also plasmalogens, which act synergistically with SP-B in the adsorption and spreading of DPPC.
Three animal-derived surfactant preparations are commonly used worldwide: beractant (BE), calfactant (CA), and poractant alfa (PA). BE is a minced bovine lung extract and contains 84% phospholipids and 1.5 mol% plasmalogens.
CA is a lavage preparation from bovine lung and contains more SP-B and phospholipids than BE. PA is a concentrated, minced porcine surfactant that contains pure polar lipids and the highest amount of plasmalogens (3.8 mol%).
Given the significant differences in composition and biochemical properties between BE and PA, a Turkish group has conducted a randomized trial to evaluate the efficacy and short-term outcomes of these two surfactants in a population of 126 preterm patients with RDS. Preterm infants (<37 weeks) were randomized to surfactant treatment with PA 200 mg/kg or BE 100 mg/kg if FiO2 = 0.30. The primary outcome was FiO2 requirements at 24 hrs. Patients were followed until 40 weeks of corrected gestational age or death.
Treatment with PA resulted in significantly lower post-treatment FiO2 requirements on days 1, 3, and 5 (p<0.005) and higher extubation rates in the first 3 days after surfactant administration (81.0% vs 55.9%, p=0.004).
Significantly more patients in the BE group required =2 doses of surfactant compared with the PA group (31% vs 12%, p=0.023). Overall mortality and morbidities were similar between groups. Survival free of bronchopulmonary dysplasia (BPD) at the end of study period was 78.7% and 58.5% in PA and BE groups, respectively (p=0.015).
In conclusion, these data indicate that preterm infants with RDS treated with PA have a more favorable outcome in terms of lower oxygen need and faster weaning from mechanical ventilation compared with those receiving BE. This study and the previous studies consistently delineate some clinical benefit with the use of PA over BE. However, larger studies are necessary to confirm the impact on BPD and/or mortality as a primary outcome between the different animal-derived surfactants.

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