A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome

Abstract

Objective To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil, regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to 1500g and diagnosed with respiratory distress syndrome.Methods Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant (Butantan group) or one of the following surfactants: Survanta® or Curosurf®. Newborns receiving Survanta® or Curosurf® comprised the control group. The main outcome measures were mortality rates at 72 hours and at 28 days of life; the typical complications of prematurity as evaluated on the 28th day of life were defined as secundary outcomes.Results No differences were observed between the Butantan (n=154) and control (n=173) groups in relation to birth weight, gestational age, sex, and prenatal use of corticosteroids, or in mortality rates both at 72 hours (14.19% versus 14.12%; p=0.98) and at 28 days (39.86% versus 33.33%; p=0.24) of life. Higher 1- and 5-minute Apgar scores were observed among control group newborns. No differences were observed as regards the secondary outcomes, except for greater need for supplemental oxygen and a higher incidence of interstitial pulmonary emphysema in the Butantan group.Conclusion The mortality rates at 72 hours and 28 days of life and the incidence of major complications of prematurity were comparable to those found with the animal-derived surfactants commercially available in Brazil, showing the efficacy and safety of the new surfactant in the treatment of respiratory distress syndrome in newborns.

Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes

“…The studies excluded from the systematic review were two full text duplicates [24, 25] reporting the same data with major methodological flaws (lack of randomization, unclear analysis, lack of allocation concealment and blinding, unclear sample size calculation, unclear outcome definition and incomplete outcome analysis/reporting) and one abstract which did not respect the eligibility criteria [22]. Two studies [42, 43] included in the systematic review were excluded from the meta-analysis because they investigated the use of non-internationally available porcine surfactants…”

“…Fifteen out of sixteen papers were in English, one was in Spanish [43] and was evaluated without translation, since two authors (AT,DDL) speak Spanish. Two studies [42, 43] were excluded from the meta-analysis because they investigated the use of non-internationally available porcine surfactants.…”

Gender-related efficacy of pulmonary surfactant in infants with respiratory distress syndrome

“…[ 3 ] This therapy has been shown to markedly reduce pneumothorax and mortality in many clinical reports. [ 4 ] However, for some infants, death is inevitable, despite intensive care and PS replacement therapy.…”

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

“…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].…”