Surfactantreplacement therapy for respiratory distress. This study was conducted to compare the efficacy of two types of natural surfactants, poractan alfa curosurf and alveofact, in the treatment of respiratory distress syndrome rds. Overall mortality and morbidities were similar between groups. Curosurf poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. In vitro characterization and in vivo comparison of the. Curosurf is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. In this study, we assessed the influence of exogenous poractant alfa curosurf instillation on the in vivo phagocytosis of apoptotic neutrophils by alveolar macrophages. The aim of this study was to investigate the feasibility of delivering nebulized surfactant poractant alfa in. Recently, we have prospectively evaluated the differences in clinical. The administration of exogenous surfactants, including curosurf, can rapidly affect oxygenation and lung compliance. Poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. In vitro characterization and in vivo comparison of the pulmonary outcomes of poractant alfa and calsurf in ventilated preterm rabbits plos one, mar 2020 xiaojing guo, siwei luo, davide amidani, claudio.
Infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant. Your doctor will tell you when your child should not receive this medicine. Poractant alfa is administered as a bolus, via the endotracheal tube, using a syringe containing the appropriate dose of poractant alfa, attached to a shortened, 5 french endhole catheter. They found no significant differences in the outcomes between two types of surfactants. Despite an increased use of noninvasive ventilatory strategies and gentle ventilation, pneumothorax remains a common complication in preterm infants. Curosurf poractant alfa intratracheal suspension is available in sterile, readytouse, rubberstoppered clear glass vials containing one vial per carton. Aug 31, 2017 treatment of the rabbits with poractant alfa 100 mgkg rapidly restored the mean oi to baseline values, already at 5 min. The 4 aliquots are administered separately followed by at least 30 seconds of ventilation until the infant is stable. Management of pneumothorax in hemodynamically stable. Further investigation is warranted to exclude these products as potential sources of hev infection.
Jan 02, 2020 curosurf poractant alfa is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Frontiers in vivo evaluation of the acute pulmonary. A randomized, multicenter masked comparison trial of poractant alfa curosurf versus beractant survanta in the. Ramanathan r, rasmussen mr, gerstmann dr, finer n, sekar k, north american study g.
Each ml of suspension contains 80 mg poractant alfa surfactant extract that includes 76 mg of phospholipids and 1 mg of protein of which 0. Group 1 n146, surfactantta, group 2 n96, calfactant, and group 3 n90, poractant alfa. Follow instructions carefully regarding installation of drug and ventilation of infant. Dec 01, 20 dear editor, we read with interest the paper by paul et al. Cases of sporadic, locally acquired hepatitis e have been increasingly identified in industrialized countries over the last few years. To compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in. Curosurf poractant alfa intratracheal suspension is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. A total of 332 preterm infants at 2431 weeks gestation with respiratory distress syndrome rds were enrolled and allocated to three groups according to the surfactant instilled. Poractant alfa is an exogenous pulmonary surfactant extracted from porcine lungs. Curosurf is an extract of natural porcine lung surfactant consisting of 99%. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa.
Bhatia is an associate editor, and sekar is a member of the editorial. Curosurf summary of product characteristics smpc emc. In addition, we tested the heparin samples for porcine circovirus 2. Curosurf there may be other brand names for this medicine. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Each milliliter of poractant alfa contains 80 mg of surfactant extract that includes 76 mg of phospholipids and 1 mg of protein of which. Pdf background poractant alfa curosurf and bovactant alveofact are two animalderived pulmonary surfactants preparations approved. In vitro characterization and in vivo comparison of the pulmonary outcomes of poractant alfa and calsurf in ventilated preterm rabbits plos one, mar 2020 xiaojing guo, siwei luo, davide amidani, claudio rivetti, giuseppe pieraccini, barbara pioselli, silvia catinella, xabi murgia, fabrizio salomone, yaling xu, et al. We would like to express our congratulations to dr engle and the american academy of pediatrics committee on fetus and newborn on the publication of their clinical report surfactantreplacement therapy for respiratory distress in the preterm and term neonate. As dr kattwinkel points out, the simplistic approach of delivering only phospholipids to infants with. It is more concentrated than other lung surfactants i. Most of the early trials of poractant alfa were in europe where it has been approved for marketing for more than 10 years. They are basically identical and the only difference is the.
Consumer information use if your childs symptoms or health problems do not get better or if they become worse, call your childs doctor. Poractant alfa definition of poractant alfa by medical. The primary outcome was being alive and extubated at 48 hours post. Methods this was a prospective, longitudinal, singlecenter cohort study of infants born at. Pdf comparison of poractant alfa and lyophilized lucinactant in a. Pdf editor snpedfz10948 modules users1 licenseestephan huck licensedate200709 sig. Curosurf poractant alfa suspension for intratracheal use is a sterile, nonpyrogenic pulmonary surfactant intended for intratracheal use only. Survival free of bronchopulmonary dysplasia bpd at the end of study period was 78. F 1166 bom january april, 2015 issue i volume viii. Three different poractant alfa doses were delivered. Comparison of the efficacy and safety of bovine lung phospholipid.
Poractant alfa and calsurf are two natural surfactants widely used in. In response to mortality in preterm infants with respiratory. Efficacy of surfactantta, calfactant and poractant alfa. The 4 aliquots are administered separately followed by at least 30 seconds of ventilation until. An official publication of iap neonatology chapter society regn no. Curosurf poractant alfa is intended for intratracheal use only. Rates of reintubation and duration of mv after reintubation were determined from 1546 preterm infants enrolled in two surfactant trials comparing lucinactant to beractant and poractant alfa. United states court of appeals for the second circuit august term, 2012. Study design randomized, partiallyblinded, multicenter trial. Mortality in preterm infants with respiratory distress syndrome. Collectively, outcomes were similar with beractant and poractant alfa in rwe studies and pooled rcts. We found a significantly higher mortality rate in infants who received more than. Infants alfa prevents and treats certain lung problems in premature infants.
For that purpose, we first analyzed the aerosol characteristics of nebulized poractant alfa curosurf, chiesi farmaceutici spa, parma, italy. March2000 volume45 number3 issn002024recacp amonthlysciencejournal 44thyearestablished1956 j 46thinternationalrespiratorycongress october710cincinnati. Poractant alfa is a pulmonary surfactant sold under the brand name curosurf by chiesi farmaceutici. Nov 17, 2019 if you need to store poractant alfa curosurf at home, talk with your childs doctor, nurse, or pharmacist about how to store it. Hepatitis e virus and porcinederived heparin volume 19. Poractant alfa is an extract of natural porcine lung surfactant. Noninvasive delivery of nebulized surfactant has been a neonatology longpursued goal. Poractant alfa versus beractant in the treatment of preterm. Methods poractant alfa 200 mgkg was instilled intratracheally in the lungs of three months old adult male c57black 6 mice, followed by apoptotic neutrophil instillation. A pharmacoeconomic analysis of inhospital costs resulting. Dear editor, we read with interest the paper by paul et al. For that purpose, we first analyzed the aerosol character istics of nebulized poractant alfa curosurf, chiesi. Poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. We read with interest dr kattwinkels commentary1 on our recently published studies2,3 comparing the new surfactant, lucinactant, to current commercially available surfactants.
Nevertheless, the clinical efficacy of nebulized surfactant remains inconclusive, in part, due to the great technical challenges of depositing nebulized drugs in the lungs of preterm infants. Sinha sk, lacazemasmonteil t, valls i soler a, et al, for the surfaxin therapy against respiratory distress syndrome collaborative group. However, we observed a trend towards higher mortality in the poractant alfa group. Pharmaceutics free fulltext in vitro performance of. Umberto simeoni, centre hospitalier universitaire vaudois, france. In response to mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant. Pdf neurodevelopmental outcomes of very low birth weight.
The recommended initial dose of curosurf poractant alfa intratracheal suspension is 2. The authors were given, and took, the opportunity to respond to those letters. It is a natural porcine lung extract consisting of 99% polar lipids mainly phospholipids and approximately 1% hydrophobic low. Semiquantitative data were accessed by manual peak integration of the. Birge and sonnesyn report the first death of a min nesota resident caused by powassan virus powv. Sales of curosurfr poractant alfa, a pulmonary surfactant, exceeded euro200m, growing by 14. Lambs received either poractant alfa or lyophilized lucinactant and were monitored for 3 hrs post treatment. The administration of poractant alfa can rapidly affect oxygenation and lung compliance. Refer to specific instruction provided by manufacturer for proper dosing technique. In vitro characterization and in vivo comparison of the pulmonary. Poractant alfa curosurf, chiesi framaceutici, parma, italy is a natural surfactant suspension, prepared from minced porcine lungs, containing almost exclusively polar lipids, in particular, phosphatidylcholine pc, about 70% of the total phospholipid content, and about 1% of specific low molecular weight hydrophobic proteins spb and spc, at a phospholipid. We write to address specific comments and explicate our purpose in undertaking this research. Poractant alfa versus bovine lipid extract surfactant for. Poractant alfa may be more beneficial and associated with fewer complications than bovine lipid extract surfactant.
In a study of 146 babies with respiratory distress syndrome the 28day mortality rate was 31% in the group who received poractant compared with 51% in the group who did not. The intratracheal it administration of budesonide using surfactant as a vehicle has been shown to reduce the incidence of bronchopulmonary. Poractant alfa curosurf worlds leading surfactant composition. Poractant alfa versus beractant in the treatment of preterm infants. Therefore, infants receiving curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to. Pdf in vivo evaluation of the acute pulmonary response to. Journal editor for giving us the opportunity to clarify all the issues that were. Fill the catheter with poractant alfa and discard excess through the catheter so that only the total dose to be given remains in the syringe. Overall, this document was comprehensive in scope yet sufficiently detailed and referenced to provide practical. Treatment of the rabbits with bovactant 50 mgkg improved the oi values but to a lesser extent than poractant alfa, which accounted for significantly better oi values favoring poractant alfa at 5 and 30 min following. Curosurf poractant alfa is an intratracheal suspension available in a sterile, readytouse rubberstoppered clear glass vials containing 1. Jan 30, 20 in response to mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, calfactant or beractant. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Poractant alfa curosurf the royal childrens hospital. Curosurf is distributed 2plaintiff also moved for expedited treatment of this discovery motion, which this court denied docket no. In this setting, hepatitis e is thought to be a zoonotic. It is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. Survanta beractant dose, indications, adverse effects. Beractant and poractant alfa in premature neonates with respiratory.
Objectives to compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants. Poractant alfa poraktant alfa prevents and treats certain lung problems in premature infants. This is a single center double blind, randomized control trial of using nebulized surfactant poractant alfa in preterm infants 29 0 33 6 weeks gestation within the first 4 hours of life. Therefore, infants receiving curosurf should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. Poractant alfa australian prescriber nps medicinewise. Pdf comparing the efficacy of two natural surfactants. Infants poractant alfa or bovine lipid extract surfactant. Acknowledgment we thank the chief scientist office of scotland who funded this work under project etm32. Curosurf is a lung surfactant indicated for the treatment of respiratory distress syndrome in premature infants. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids mainly phospholipids and 1% hydrophobic low molecular weight proteins surfactant associated proteins spb and spc. Genderrelated efficacy of pulmonary surfactant in infants.