Less invasive surfactant administration versus intubate-surfactant-extubate in extremely preterm infants with RDS. A step forward. Multicenter, randomized, controlled clinical trial

Abstract

Background: Pulmonary Surfactant therapy is commonly used for the treatment of the respiratory distress syndrome. This therapy is usually given to preterm infants who are mechanically ventilated using an endotracheal tube; however, non-invasive ways of administration are in study and try to avoid mechanical ventilation by the application of surfactant to spontaneously breathing infants. A method of surfactant delivery using a gastric catheter trough the trachea during spontaneous breathing with nCPAP seems to be potentially effective, reducing the need of MV and the incidence of Bronchopulmonary Dysplasia, and requires more investigation. Objective: The main aim of this study is to evaluate whether LISA technique is related to a lower need of MV and to a lower rate of BPD in extremely preterm infants with Respiratory Distress Syndrome than in infants treated with INSURE. Design: This study has been designed as a multicenter, randomized, two group controlled clinical trial, in which the reference center will be Hospital Universitari Doctor Josep Trueta, during a period of time of two years and six months. Methods: Preterm infants with GA<32weeks and with surfactant requirements, who can be stabilized with nCPAP in the delivery room, will be randomized to receive pulmonary surfactant therapy either by LISA procedure or INSURE technique. In both groups patients receive a dose of 200mg of Poractant α and will be followed up during a period of three months