Animal-derived surfactants for the treatment and prevention of neonatal respiratory distress syndrome: summary of clinical trials

Abstract

Introduction: Available literature suggests that the advantage of animal-derived surfactants over fi rst-generation synthetic agents derives from the presence of surface-active proteins and their phospholipid content. Here we summarize the results of clinical trials comparing animalderived surfactant preparations with other animal-derived surfactants and with both fi rst-and second-generation synthetic surfactants. Methods: Published clinical trials of comparisons of animal-derived surfactants were summarized and compared. Comparisons emphasized differences in (1) key surfactant components attributed with effi cacy and (2) differences in published outcomes. Results: For the most important outcomes, mortality and chronic lung disease, currently available natural surfactants are essentially similar in effi cacy. When examining secondary outcomes (pneumothorax, ventilator weaning, and need for supplemental oxygen), it appears that both calfactant and poractant have an advantage over beractant. The weight of the evidence, especially for study design and secondary outcomes, favors the use of calfactant. However, the superiority of poractant over beractant, when the higher initial dose of poractant is used, strengthens the case for use of poractant as well. Conclusions: Clinical trials suggest that the higher surfactant protein-B content in calfactant, and perhaps the higher phospholipid content in poractant (at higher initial dose), are the factors that most likely confer the observed advantage over other surfactant preparations.

Comparative efficacy and safety of late surfactant preparations: a retrospective study

“…Overall study findings are consistent with a comparative effectiveness study of on-label surfactant that found no significant differences in air leak syndrome, BPD, or death among the three surfactants [ 17 ]; three efficacy trials that identified no significant differences in mortality or oxygen requirement at 36 weeks [ 20 – 23 ]; and another study, in which poractant alfa compared to beractant was associated with nonsignificant trends towards lower death and/or, BPD in infants 24–29 weeks GA [ 6 ]. In contrast to our results, prior studies identified significant benefits to poractant alfa [ 6 , 7 , 9 ]; but some observed outcomes appear due to differences in dosing [ 9 , 24 , 25 ].…”

The Role of Surfactant in Respiratory Distress Syndrome

“…Compared to beractant, calfactant has higher phospholipid content (95% vs 84%) and a greater SP-B concentration (5.4ug/umol vs 1.3ug/umol), suggesting improved surfactant effect [ 35 ]. In contrast, poractant (Curosurf ® ) is extracted from minced porcine lungs and undergoes a series of purification procedures by centrifuge to remove neutral lipids [ 10 ]. SP-B and SP-C are the only two protein types present [ 36 ].…”

“…With the various natural surfactant subtypes available in the market, trials have sought to compare the efficacy of these surfactants (Table 3 ). A meta-analysis [ 10 ] identified three trials comparing beractant to calfactant [ 46 - 48 ], while four trials compared beractant to poractant [ 49 - 52 ]. No trials evaluated the efficacy of calfactant versus poractant.…”

“…Animals used in this process include pigs and cows. There are three commonly researched natural surfactants [ 10 ]. First, poractant (Curosurf ® ) is derived from minced porcine lungs [ 11 ].…”

Clinical effects of pulmonary surfactant in combination with nasal continuous positive airway pressure therapy on neonatal respiratory distress syndrome

“…It is induced by the lack of pulmonary surfactant (PS), 1 , 2 accounting for 50%-70% of premature deaths. 3 Its main pathogenesis is alveolar collapse due to immature pulmonary development of neonates and insufficient PS secretion, and its clinical manifestations include progressive dyspnea and respiratory failure shortly after birth. PS is a natural mixture derived from porcine lung or bovine pulmonary homogenate with phospholipids and specific proteins as the main ingredients, containing 41% to 48% of lecithin and 51% to 58% of other phospholipids and 1% of hydrophobin.…”