May 7, 2007 - Data presented at the Pediatric Academic Societies' Annual Meeting demonstrate that premature infants with neonatal Respiratory Distress Syndrome (RDS) have a nearly 20 percent better chance of survival if they are treated with Curosurf (poractant alfa) Intratracheal Suspension rather than either of two competing surfactant therapies.
"Differences in Mortality Among Infants Treated with Three Different Natural Surfactants for Respiratory Distress Syndrome (RDS)," a retrospective analysis of a very large database maintained by Premier Inc., considered specific procedures and clinical outcomes for 24,883 premature infants treated for RDS at 191 U.S. hospitals from January 2003 to June 2006. The alternative surfactant therapies over which Curosurf Intratracheal Suspension showed a nearly 20 percent mortality advantage are Survanta (beractant) and Infasurf (calfactant).
Full disclosure of the data are being held pending publication. Jatinder J. Bhatia, MD, Professor and Chief, Section of Neonatology in the Department of Pediatrics, Medical College of Georgia, commented, "Clinicians have long needed a robust basis upon which to choose surfactant therapies for premature babies suffering form RDS. Even though natural surfactants have appeared for some time to perform better than synthetic ones, and despite the significant differences in mortality that randomized trials have suggested among the three commonly available natural surfactants, there has been no single study comparing the mortality rates of all three natural surfactants."
According to Dr. Bhatia, "The present research analyzes summary data from an extensive administrative database of actual 'real-world' clinical outcomes. The sheer size of the sample as well as the consistency of its results across different hospital settings underscores the validity of the findings. The study controlled for six variables that could have confounded results, and derived data both for the total sample of nearly 25,000 babies as well as for a somewhat smaller group of more than 21,000 babies for whom complete and comparable data are available. For both groups, death rates were nearly 20 percent lower for babies treated with poractant alfa than for those treated with either beractant or calfactant."
RDS is a condition caused by a deficit in lung surfactant in infants who are born prematurely. Surfactant, a necessary and natural substance, is typically produced in the body about two months prior to birth and is required for proper respiratory function. By reducing the surface tension within the lungs, surfactant enables the lungs to inflate and normal breathing to begin at birth. However, when infants are born pre-term, surfactant may either be absent or be present only in insufficient quantities, preventing the lungs from inflating properly and possibly leading to the development of RDS. The administration of surfactants such as Curosurf Intratracheal Suspension has been widely used to increase infant lung function and decrease the morbidity and mortality associated with RDS.