Initial clinical trial of EXOSURF, a protein-free synthetic surfactant, for the prophylaxis and early treatment of hyaline membrane disease

Infants born prematurely often suffer from hyaline membrane disease, also known as respiratory distress syndrome, in which the lungs are unable to function properly because they are immature. A substance called surfactant is lacking in the infant's lungs. Previous studies have shown that protein-containing lung surfactants from other species can be processed and given to infants with the disease to lessen its severity and increase survival. The protein portion helps in absorption of the surfactant, but increases the risk for infection or immunologic rejection and is difficult to produce on a large scale. This study examined the effectiveness of a new synthetic surfactant, EXOSURF, that does not contain proteins, for treating infants with hyaline membrane disease. The drug was given through the trachea (windpipe) to two sets of infants soon after birth. There were 74 high-risk infants weighing between 700 and 1,350 grams (1.5 to 3 pounds) who were given the drug or a placebo at birth as a preventive measure (prophylactic trial), and 104 infants with the disease weighing more than 650 grams (1.4 pounds), who were given EXOSURF as a treatment or were given a placebo (rescue trial). In the prophylactic trial, 36 received the drug and 38 received the placebo. Within the first three days after birth, six infants given placebo died of respiratory failure while none of the prophylactically treated infants died until one died at age 34 days. In the rescue trial, 53 infants received the surfactant and 51 received a placebo. Complication and death rates were not significantly different between the treated group and the placebo group. In both trials, the treated group did have significantly greater improvements in respiratory function than the placebo group. These results indicate that EXOSURF, a synthetic surfactant, is as effective as surfactants derived from animals in treating hyaline membrane disease, with the added benefit that the former does not contain proteins. (Consumer Summary produced by Reliance Medical Information, Inc.)