Evaluating Less Invasive Surfactant Treatment to Improve Survival in Preterm Infants with Respiratory Distress in Africa

What this Trial Is About

Researchers are evaluating the use of surfactant given by a less invasive surfactant administration LISA technique to treat respiratory distress syndrome in preterm infants in low- and middle-income African countries. This pragmatic clinical trial aims to determine whether this method improves survival compared to standard care, especially where invasive ventilators are not available. The study focuses on preterm neonates with respiratory distress who are managed with continuous positive airway pressure CPAP and caffeine citrate. The trial compares two groups one receiving standard care with CPAP and caffeine citrate, and the other receiving surfactant therapy administered through the LISA technique, which involves instilling surfactant into the lungs via a thin catheter during laryngoscopy while on CPAP. Participants are preterm infants born between 24 and 35 weeks gestation or weighing between 750 and 2000 grams with respiratory distress defined by a Silverman Anderson Score of 5 or greater. The study includes monitoring for complications and follows infants throughout hospitalization. Participants will be observed during their hospital stay, which averages about six months, to assess survival and other health outcomes such as incidence of major preterm neonatal morbidity and pneumothorax. Researchers will monitor participants from admission within 24 hours of life until discharge, evaluating hospital survival and complications related to respiratory distress and surfactant treatment. The primary outcome is all-cause in-hospital survival.

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa