EXOGENOUS SURFACTANT THERAPY - DEFINITION AND VALIDATION OF THE OPTIMAL DOSE IN NEONATES

Natural surfactant is an endogenous complex of phospholipids and prote ins that prevents the pulmonary alveoles from collapsing during the fi rst expirations after birth. in premature infants, quantitative or qua litative surfactant deficiency results in decreased alveolar expansion , gradual collapse of the alveoles, and respiratory distress in the im mediate postnatal period. The two surfactants available on the French market, since 1992, are Surfexo Neonatal(R), which is synthetic, and C urosurf(R), which is semi-natural, Both have been proved effective for the treatment of respiratory distress syndrome in premature infants. The doses recommended in the marketing authorizations of these drugs w ere established based on in vitro studies, preclinical studies in imma ture animals, and clinical studies in premature infants. These studies focused mainly on establishing the efficacy of the product and did no t provide conclusive evidence that the recommended dosage is optimal. Further clinical studies of both drugs were therefore conducted to det ermine the optimal dose and dose spacing. These studies demonstrated t hat there is no convincing evidence to date that the recommended dosag es should be modified.