NEWS HIGHLIGHTSMedia Articles Related to Curosurf (Poractant Alfa)
ARDS (Acute Respiratory Distress Syndrome)
Source: MedicineNet Endotracheal Intubation Specialty [2007.03.12]
Title: ARDS (Acute Respiratory Distress Syndrome)
Category: Diseases and Conditions
Created: 3/12/2007
Last Editorial Review: 3/12/2007
Published Studies Related to Curosurf (Poractant Alfa)
A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome. [2005.06]
AIM: To compare the effects of beractant and poractant in neonatal respiratory distress syndrome (RDS)... CONCLUSIONS: Infants with RDS treated with poractant had a lower FiO2 requirement during the first 48 h compared to infants who received beractant. Infants who received poractant also had fewer PDAs than infants who received beractant. The difference in FiO2 was not associated with a difference in age of first extubation, total intubation time, or incidence of bronchopulmonary dysplasia between groups.
A multicenter, randomized, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome. [2005.04]
BACKGROUND: Available therapeutic surfactants are either animal-derived or non-protein-containing synthetic products. Animal-derived surfactants contain variable amounts of surfactant apoproteins, whereas the older-generation synthetic products contain only phospholipids and lack surfactant proteins (SPs). Both decrease morbidity and mortality rates associated with respiratory distress syndrome (RDS) among preterm infants, compared with placebo. However, excess mortality rates have been observed with non-protein-containing synthetic surfactants, compared with the animal-derived products. Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved with the addition of peptides that are functional analogs of SPs. Lucinactant is a new synthetic peptide-containing surfactant that contains sinapultide, a novel, 21-amino acid peptide (leucine and lysine repeating units, KL4 peptide) designed to mimic human SP-B. It is completely devoid of animal-derived components. OBJECTIVE: We hypothesized that the outcomes for premature infants treated with lucinactant and poractant alfa would be similar. Therefore, we compared lucinactant (Surfaxin; Discovery Laboratories, Doylestown, PA) with porcine-derived, poractant alfa (Curosurf; Chiesi Farmaceutici, Parma, Italy) in a trial to test for noninferiority... CONCLUSIONS: Lucinactant and poractant alfa were similar in terms of efficacy and safety when used for the prevention and treatment of RDS among preterm infants. The ability to enhance the performance of a synthetic surfactant with the addition of a peptide that mimics the action of SP-B, such as sinapultide, brings potential advantages to exogenous surfactant therapy.
A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. [2004.04]
We compared the onset of clinical response and safety of two surfactants, poractant alfa (Curosurf, Chiesi Pharmaceuticals, Parma, Italy) and beractant (Survanta, Ross Laboratories, Columbus, OH), for treatment of respiratory distress syndrome (RDS) in preterm infants weighing 750 to 1750 g at birth and <35 weeks gestation...
Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: a randomised trial. [2000.04.22]
BACKGROUND: Exogenous surfactant preparations vary in their constitution and biophysical properties. Synthetic and animal-derived preparations lower the rate of death compared with controls. No significant differences in mortality or important long-term clinical outcomes have been shown between them in randomised trials. We did a randomised controlled trial to compare pumactant, a synthetic surfactant, with poractant alfa, an animal-derived surfactant, both of which are widely used in the UK... INTERPRETATION: Mortality was unexpectedly lower among neonates who received poractant alfa than among those who received pumactant, and was independent of all the variables we investigated. Stopping the trial early may have widened the difference between the treatment groups.
Theoretical changes in neonatal hospitalisation costs after the introduction of porcine-derived lung surfactant ('Curosurf'). [1995.10]
The aims of this study were to determine the effects of porcine-derived lung surfactant (PLS; 'Curosurf') therapy on mortality, periods of care and hospitalisation costs in a model cohort of 1000 premature neonates. In this cohort, 55% of the neonates would develop respiratory distress syndrome (RDS) and this would result in a mortality rate of 35%...
Clinical Trials Related to Curosurf (Poractant Alfa)
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants [Recruiting]
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome
(RDS) in premature infants greatly improved survival rates. Newer surfactants approved by
the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of
newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a
double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared
to infants treated with Survanta, the most commonly used surfactant preparation in the
United States. While the data was suggestive, it was not clear that the improvement in
survival was reproducible or that Curosurf was responsible for the improved survival rates.
The purpose of this study was to investigate the role of Curosurf in improving lung function
and survival rates and reducing the complications of prematurity in very premature infants <
30 weeks gestational age at birth.
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study [Recruiting]
The primary objective of this study is to compare two methods of post-delivery stabilization
and subsequent early respiratory care for reducing the need for MV and related secondary
complications, such as BPD, in premature babies at high risk of RDS:
1. Early stabilization on nCPAP
2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery,
and rapid extubation to nCPAP.
The data obtained from this comparison will be applied to test the hypothesis that preterm
neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need
for MV when compared to infants who receive nCPAP alone.
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks [Not yet recruiting]
This study investigates the efficacy of surfactant application during spontaneous breathing
with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a
gestational age of less than 27 weeks
Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress [Recruiting]
Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized
Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive
Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory
Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early
extubation [within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation
(NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the
incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6
weeks gestation premature infants with respiratory distress treated with intratracheal
Curosurf (poractant alpha) within 60 minutes of birth.
Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and
36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse
events.
Number of Subjects: 110
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis [Completed]
The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid
ethyl ester 90) on the incidence of cardiovascular events and mortality in patients
undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
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