Estudio clínico de un Nuevo surfactante natural de extracción bovina en el tratamiento del síndrome de dificultad respiratoria neonatal.
Dres. Eduardo Halac, Cristina Ottino, José M. Paisani y Lic. Klg. Ricardo J. Obregón.
Introduction . Exogenous surfactants are considered an important part in the treatment of neonatal respiratory distress syndrome.
Objectives. To evaluate the efficacy, effectiveness and efficiency of a new natural surfactant extracted by alveolar lavage from young bovine lungs.
Population. Appropriate for gestational age preterm newborns admitted to an intensive care neonatal unit, diagnosed as having respiratory distress syndrome, type I and requiring mechanical ventilation.
Methods. Random surfactant samples from ready-to-use vials were analyzed for surface active properties and chemical composition and compared with data provided by the manufacturer of the new product.
Selected patients were randomized to receive either of two known products: Survanta and Natsurf. In the experimental arm, the new surfactant Baby-Fact was used. All infants received three doses of surfactants, 8 hours apart.
Main outcome measures. Changes in arterial blood gases, oxigenation indexes, mean airway pressures, oxygen a/A ratios, specific and general (before discharge) mortality, incidence of chronic lung disease, and adverse effects during instillation. Incidence rates for apnea, air-leak syndromes, necrotizing enterocolitis, retinopathy of prematurity, patent ductus arteriosus, intraventricular hemorrhage and leukomalacia were determined.
Results. Surface active capacity and chemical composition of the new product were not significantly different from those reported by the manufacturer. Neither significant differences nor valid associations were found for the different outcome measures for any of the surfactants studied. Both survival and chronic lung disease rates were similar in all groups. Cost-benefit ratios indicate a better performance for the new product, compared to the other two, despite similar profiles of clinical effectiveness.
Archivo Argentino Pediatría. 2002; 100 (2): 120 – 129