Surfactant for Neonatal Respiratory Distress Syndrome (NRDS) and Neonatal Acute Respiratory Distress Syndrome (NARDS)

What this Trial Is About

Researchers are studying preterm infants with neonatal respiratory distress syndrome (NRDS) and neonatal acute respiratory distress syndrome (NARDS) to understand how different doses of pulmonary surfactant (PS) replacement therapy affect outcomes. While PS is widely used to treat newborns with respiratory distress, its benefits are inconsistent, especially regarding bronchopulmonary dysplasia (BPD) and death rates. The study aims to clarify whether one or multiple doses of PS better support preterm infants diagnosed with NRDS and NARDS, conditions that require differentiation based on recent consensus definitions. The study compares two groups of preterm infants diagnosed with NRDS and/or NARDS: one group receives only one dose of surfactant replacement, while the other group receives two or more doses. These treatments are administered after admission to the neonatal intensive care unit within 24 hours of birth. The research focuses on evaluating the predictive power of surfactant dosing for diagnosing NRDS and NARDS and assessing the impact on neonatal outcomes. Participants will be monitored until 36 weeks' gestational age or hospital discharge. Researchers will assess primary outcomes including bronchopulmonary dysplasia, death, and a combined measure of BPD and/or death. Secondary outcomes such as intraventricular hemorrhage, air leak, periventricular leukomalacia, necrotizing enterocolitis, patent ductus arteriosus, and late-onset sepsis will also be tracked. The study involves clinical observation, diagnosis confirmation, and surfactant administration with ongoing evaluation of health status during the hospital stay.

Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)