Neurodevelopmental Outcomes of Very Low Birth Weight Preterm Infants Treated With Poractant Alfa versus Beractant for Respiratory Distress Syndrome

Abstract

Our findings suggest that poractant alfa and beractant are similar in terms of neurodevelopmental outcomes when used for the treatment of RDS in preterm infants.

Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials

“…Fourteen studies had mid-term to long-term outcomes (>72 h) [ 19 , 20 , 22 – 33 ], and 1 study had short-term outcomes (≤72 h) [ 21 ]. The criterion for gestational age was <37 or ≤37 wGA in five studies [ 22 , 24 , 25 , 29 , 32 ], <35 wGA in two studies [ 19 , 26 ], ≤32 wGA in three studies [ 20 , 27 , 28 ], <30 wGA in one study [ 31 ], 26–36 wGA in one study [ 33 ], and 24 to <30 wGA in one study [ 21 ]. Two studies simply stated that patients had to be preterm, without defining a specific gestational age [ 23 , 30 ].…”

“…The studies included between 30 and 293 patients. Nine studies included data about doses that were administered according to the US product label (i.e., beractant 100 mg/kg; poractant alfa 200 mg/kg for the first dose, and 100 mg/kg for subsequent doses) [ 19 , 20 , 22 , 23 , 25 , 27 , 29 , 31 , 33 ]. Six studies specifically compared beractant 100 mg/kg with poractant alfa 100 mg/kg [ 19 , 24 , 26 , 28 , 30 , 32 ].…”

Porcine versus bovine surfactant therapy for RDS in preterm neonates: pragmatic meta-analysis and review of physiopathological plausibility of the effects on extra-pulmonary outcomes

“…Compared to our previous metaanalysis on respiratory endpoints, there was one more study reporting on the extra-pulmonary outcomes [45]. This study did not report the exact dose of surfactant [45]. Moreover, Fujii et al reported hemodynamically significant PDA in one paper and other extra-pulmonary outcomes in a second manuscript [30,31].…”

“…Additionally, we also searched PubMed, using key words and/or MeSH terms as described in the Additional file 1, looking for animal or human translational investigations on these mechanisms. Fig.1 illustrates the project flow-chart: we included 17 studies in the systematic review [28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45] and we excluded two papers from the meta-analysis, as they investigated two non-internationally marketed porcine surfactants [43,44]. Compared to our previous metaanalysis on respiratory endpoints, there was one more study reporting on the extra-pulmonary outcomes [45].…”

“…It is important to remind that the incidence of these extra-pulmonary neonatal outcomes have never been changed with the use of any surfactant, neither in the early trials conducted decades ago [80,81], nor in the more recent ones, as acknowledged by the American Academy of Pediatrics both in 2008 and 2014 guidelines [3,59]. Moreover, these outcomes were not changed when comparing surfactant therapy with prophylaxis and surfactant replacement increases survival rates without a change in the incidence of long-term neuro-developmental injury [45,59]. Therefore, the lack of clear physiopathological plausibility and the preponderance of evidence suggest that the incidence of these outcomes is not significantly affected by any type of surfactant therapy.…”