Comparison of the Therapeutic Effects of Curosurf(R) and Newfactan(R) in Respiratory Distress Syndrome

PURPOSE: The aim of this study was to compare the clinical effects of modified porcine (Curosurf(R)) and bovine (Newfactan(R)) surfactants in the treatment of neonatal respiratory distress syndrome. METHODS: Between April 2004 and December 2006, 65 neonates (birth weight < or =2,500 g and gestational age < or =35 weeks) with neonatal respiratory distress syndrome were treated in our neonatal intensive care unit with surfactant. Thirty-one neonates received Curosurf(R) and 34 neonates received Newfactan(R). The neonates were not enrolled if they had major congenital anomalies or meconium aspiration syndrome. We compared the changes in respiratory parameters after surfactant instillation, the incidences of acute and chronic complications, and the mortality between the two treatment groups. RESULTS: Neonatal and maternal demographic characteristics were not different between the groups. The patterns of change in the respiratory parameters after surfactant instillation were not statistically different between the groups. The incidences of surfactant reinstillation and acute complications, such as pneumothorax, patent ductus arteriosus, pulmonary hemorrhage, and grade 3-4 intraventricular hemorrhage, were not different between the neonates who received Curosurf(R) and the neonates who received Newfactan(R). There were no statistically significant differences in the duration of mechanical ventilation, oxygen therapy, hospitalization, prevalence of bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, and mortality between the groups. CONCLUSION: In the present comparative study, no significant differences in the clinical effects of Curosurf(R) and Newfactan(R) were observed.

Comparison of Clinical Efficacy of Newfactan(R) versus Surfacten(R) for the Treatment of Respiratory Distress Syndrome in the Newborn Infants

Newfactan(R) is a domestically developed, bovine lung-derived, semi-synthetic surfactant. The aim of this study was to compare the clinical efficacy of Newfactan(R) with that of Surfacten(R) in the treatment of respiratory distress syndrome (RDS). Newfactan(R) or Surfacten(R) was randomly allocated to 492 newborn infants who were diagnosed as RDS and required surfactant instillation in four participating hospitals. The comparisons were made individually in two subsets of infants by birth weight (or=1,500 g group [n=239]). Short-term responses to surfactant and acute complications, such as the total doses of surfactant instilled, response type, extubation rate, ventilator settings, changes in respiratory parameters, air leak, patent ductus arteriosus, pulmonary hemorrhage, and intraventricular hemorrhage, and mortality during the 96 hr after surfactant instillation were measured. Long-term outcome and complications, such as total duration of intubation, bronchopulmonary dysplasia and periventricular leukomalacia, and ultimate mortality were measured. There were no significant differences in demographic and perinatal variables, shortterm responses to surfactant and acute complications, and long-term outcome and complications between Newfactan(R) and Surfacten(R) in both birth weight groups. We concluded that Newfactan(R) was comparable to Surfacten(R) in the clinical efficacy in the treatment of RDS in both birth weight groups.

Clinical Effects of Newfactan in the Treatment of Moderate to Severe Respiratory Distress Syndrome

PURPOSE: This study was designed to investigate the clinical effects of Newfactan in the treatment of moderate to severe respiratory distress syndrome. METHODS: There were enrolled 20 preterm infants who were diagnosed as grade III or grade IV respiratory distress syndrome at Kosin University Gospel Hospital from July 1997 to May 2000. All of these preterm infants were treated for rescue. To investigate the improvement of respiratory parameters we used FiO2, MAP, a/APO2 ratio, OI. RESULTS: Newfactan was administered to the patients at 7.2+/-7.4 hours (range 1.5- 32) after birth and 7 cases (35%) were administered one dose, 8 (40%) were administered two doses and 5 (25%) were administered three doses. The dose interval from first to second dose was 9.2+/-12.3 hours (range 5-46). The dose interval from second to third dose was 27.6+/-5.4 hours (range 21-35). The need of FiO2 showed decreased tendency especially between 4 to 6 hour after administration (P0.05). There were 41 complications and outcomes including PDA, sepsis, pneumothorax, intraventricular hemorrhage, BPD, ROP, and necrotizing enterocolitis. CONCLUSION: The clinical effects of Newfactan in the treatment of grade III or grade IV respiratory distress syndrome were significant in improving FiO2, PaCO2, a/APO2 ratio and OI.

Clinical Trial of Domestically Developed Bovine Lung Surfactant YY-38 in Neonatal Respiratory Distress Syndrome

PURPOSE: We previously reported modified bovine lung surfactant YY-38(Newfactan ) had a low surface tension, good hysteresis, and exhibited good pressure-volume curve in animal experiment(J Korean Pediatr Asso 1997;40:771-85). We performed multicenter clinical trial of Newfactan in neonatal RDS. METHODS: Seventy-seven infants with RDS(GA 31.8+/-2.9 wks and BW 1,809+/-592 gm) in 4 NICU were enrolled. After administration of Newfactan , we analyzed ventilator parameters and outcomes in 71 infants excluding mortality cases(n=6), and also compared risk factors between response(n=53) and redosing group(n=18). RESULTS: Newfactan was administered at 6.8+/-7.2 hr after birth. Ventilator parameters such as FiO2, alveolar-arterial oxygen difference(a-A PO2) and oxygenation index(OI) except mean airway pressure(MAP) were significantly improved from six hours after administration. All parameters were improved at 24 hours after administration and persisted for 5 days. Outcomes were as follows; PDA(n=24), BPD(n=16), IVH(n=13), sepsis(n=9), ROP(n=7), pneumothorax(n=4) NEC(n=3), PIE(n=2), and pulmonary hemorrhage(n=1). All patients survived 30 days after birth. Redosing rate was 25%. The incidence of PDA was greater in redosing(56%) than in response group(26 %)(P=0.025). CONCLUSION: In prospective multicenter clinical trial, Newfactan was effective in the treatmentof RDS.

Comparison of in vitro Surface Physical Properties of Four Artificial Exogenous Pulmonary Surfactant Preparations

PURPOSE: We conducted this study to compare the surface physical properties of four commercial preparations of artificial exogenous pulmonary surfactants in vitro which have been used in both the prevention and treatment of respiratory distress syndrome in newborn infants. METHODS: We tested four surfactants : a) Surfacten (Tokyo Tanabe, Japan) and Newfactan (Yuhan, Korea) : reconstituted bovine lung extract, b) Curosurf (Cheisi, Italy) : porcine lung mince; chloroform-methanol extract; liquid-gel chromatography, and c) Exosurf (Wellcome, USA), synthetic surfactant composed of colfosceril, palmitate, hexadecanol, and tyloxapol. We measured the surface adsorption rate, spreading rate, and surface tension(ST)-area diagram by using modified Wilhelmy balance and minimum(min-ST) and maximum ST(max-ST) by Pulsating Bubble Surfactometer. RESULTS: The adsorption rate of Surfacten is less than 30mN/m and those of Newfactan, Curosurf, and Exosurf are more than 30mN/m. The spreading rate of Surfaten and Newfactan are less than 30mN/m, and those of Curosurf and Exosurf are more than 30mN/m. The min-ST of Surfacten and Newfacten are less than 10mN/m, and those of Curosurf and Exosurf are more than 10mN/m. According to high performance of surface physical activities, which are compared with in vitro criteria of effective artificial surfactant, they are as follows; Surfacten>Newfactan>Curosurf>Exosurf. CONCLUSION: There are some differences between the surface physical properties of the four surfactant preparations. The natural surfactants appear to be superior to synthetic surfactant in vitro. Among the natural surfactants, Surfacten showed the best surface physical activities of spreading, adsorption and ST-lowering properties.