Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome

What this Trial Is About

Respiratory distress syndrome (RDS) is a common cause of breathing failure in preterm infants and is often treated with surfactant therapy. Researchers are comparing two surfactants, poractant alfa and calfactant, to see how they perform when given using a less invasive method called LISA. This study focuses on preterm infants born before 30 weeks who have RDS but are still breathing on their own without intubation. The goal is to understand which surfactant is more effective at improving breathing and reducing complications both shortly after birth and later in infancy. In this study, preterm infants with RDS will be randomly assigned to receive either poractant alfa or calfactant surfactant via the LISA method. This technique delivers surfactant through a thin catheter into the trachea while the infant continues to breathe spontaneously with noninvasive respiratory support, avoiding the need for mechanical ventilation. Poractant alfa is dosed at 200 mg/kg initially and 100 mg/kg if repeated, while calfactant is given at 100 mg/kg for both initial and repeat doses. Both treatments follow standard clinical guidelines and are given shortly after birth. Participants will be closely monitored for respiratory outcomes during the first 72 hours of life, including whether they need intubation, additional surfactant doses, and the level of respiratory support needed. The study will also track longer-term outcomes such as bronchopulmonary dysplasia, other neonatal complications like brain bleeding and gut issues, and survival until discharge. These assessments will help determine the best surfactant option using the less invasive method to support preterm infants with RDS.

Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome