Poractant alfa and beractant treatment of very premature infants with RDS

Although many studies have evaluated the efficacy of surfactant treatment of neonatal respiratory distress syndrome (RDS), comparison of the animal-derived surfactants is incomplete. Previous studies showed that treatment with poractant alfa caused greater improvement in oxygenation and ventilator support 24 h after administration and that infants treated with poractant alfa had a shorter ventilator course, required oxygen for fewer days, and had a shorter length of stay than those on beractant. Another study indicated a decrease in mortality from 11%, in infants <32 weeks treated with beractant (100 mg/kg) or poractant alfa (100 mg/kg), to 3% in those receiving high-dose poractant alfa (200 mg/kg). Although the onset of action of poractant alfa is more rapid than beractant, it is uncertain whether poractant alfa improved morbidity or mortality.
On this basis, an American group has conducted an open-label, randomized controlled trial to determine whether there was a sustained difference in the level of ventilator support over the first 3 days between infants treated with poractant alfa and those receiving beractant. This study also evaluated whether differences in ventilator support were associated with differences in the frequency of chronic lung disease or death.
The study included preterm infants ≤29 weeks GA who required mechanical ventilation for RDS. In total, 25 infants received poractant alfa (27.1±1.6 weeks, birth weight of 930±231 g) and 27 were assigned to beractant (26.7±1.7 weeks, birth weight 900±271 g). Respiratory support for the first 72 h of life was lower in the poractant alfa than beractant group in terms of mean airway pressure (P=0.003) and respiratory index (P=0.032). Infants in the poractant alfa group had a greater number of infants extubated at 48 (13 vs 6, P=0.027) and 72 h (15 vs 8, P=0.029) than the beractant group. Although the study was not powered to detect morbidities of prematurity, frequency of hemodynamically significant PDA and air leaks was lower in infants treated with poractant alfa than in those treated with beractant (32% vs 76%, P=0.002 and 0% vs 15%, P=0.043, respectively). A trend was observed towards lower rates of bronchopulmonary dysplasia (8/23 vs 11/22, P=0.303) or death (2/25 vs 5/27, P=0.272) in the poractant alfa group as comparaed to the bearctant group, although the difference was not statistically significant.
The primary finding of this study is that treatment of RDS in very premature infants with poractant alfa results in less respiratory support during the first 3 days of life, thus allowing a greater number of patients to be extubated at 48 and 72 h of life. Of note, this is the first prospective randomized control trial reporting a prolonged early difference between poractant alfa and beractant, associated with a difference in the frequency of hemodynamically significant PDA.

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