Effect of Surfactant Delivery Duration on Vital Signs and Brain Oxygen Levels in Very Preterm Babies Under 28 Weeks

What this Trial Is About

Respiratory distress syndrome RDS frequently affects very preterm infants due to a lack of surfactant. This research evaluates whether the speed of surfactant administration using the less invasive surfactant administration LISA technique influences oxygen stability in extremely preterm babies born before 28 weeks of gestation. The trial compares giving surfactant over 1 minute versus 5 minutes to understand effects on brain and body oxygen levels. In this single-center, phase IV trial, infants needing surfactant are randomly assigned to receive poractant alfa either rapidly over 1 minute or more slowly over 5 minutes via the LISA method. The surfactant is delivered through a thin catheter while the infant breathes spontaneously with continuous positive airway pressure. The study examines two commonly used administration durations within current guidelines. Participants are continuously monitored for cerebral oxygen levels using near-infrared spectroscopy from 5 minutes before until 3 hours after surfactant delivery. Researchers also track heart rate, blood oxygen, blood pressure, and episodes of low oxygen or slow heart rate. The study aims to measure changes in cerebral oxygen saturation within 15 minutes after the procedure and observe the need for further surfactant or ventilation over 48 hours. Outcomes like lung disease and brain bleeding are assessed up to corrected ages of 36 to 40 weeks. The study plans to enroll 76 infants in total.

Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes