35 Surfactant Treatment of Spontaneously Breathing Preterm Infants to Avoid Mechanical Ventilation - a Randomized Controlled Trial

Background: Surfactant, a standard treatment for respiratory distress syndrome in preterm infants, is usually administered to mechanically ventilated infants via the endotracheal tube. In this randomized controlled trial, we evaluated a new method of surfactant application to spontaneously breathing preterm infants in order to avoid mechanical ventilation. Methods: 220 preterm infants with a gestational age between 26+0 and 28+6 weeks and a birth weight below 1500 grams were enrolled in the trial. In the intervention group, surfactant was given to spontaneously breathing infants who needed more than 30% oxygen via a thin catheter which was placed in the trachea. Results: On day two or three of life 30 (27.8%) of 108 infants in the spontaneously breathing group but 51 (45.5%) of 112 infants in the standard treatment group were mechanically ventilated (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.3-0.8, p=0.008). At 28 days, there was a lower need for oxygen therapy in the spontaneously breathing group. If any mechanical ventilation during the stay in the hospital was analyzed, 36 (33%) infants in the spontaneously breathing group but 82 (73%) infants in the standard treatment group needed intubation and mechanical ventilation (OR 0.18, 95%CI 0.1-0.3, p= 0.0000000038). The spontaneously breathing group had considerable fewer days of mechanical ventilation. No differences were observed for overall mortality and serious adverse events. Conclusions: The application of surfactant to spontaneously breathing preterm infants with a thin catheter reduces the need for mechanical ventilation.