Comparing Two Methods of Surfactant Delivery to Help Preterm Babies Breathe A Clinical Trial for Infants Born at or After 29 Weeks Needing Breathing Support

What this Trial Is About

Researchers are comparing two methods of giving surfactant, a medicine that helps premature infants breathe better. The study focuses on infants born at or after 29 weeks of pregnancy who have trouble breathing. It aims to find out which of the two methods, the Less Invasive Surfactant Administration LISA using a thin tube or Surfactant Administration through Laryngeal or Supraglottic Airway SALSA using a small airway device, is safer and more effective. The study also tests if the SALSA method reduces breathing problems and short-term complications. Participants will receive surfactant either through the SALSA method with supraglottic airway devices sizes S, M, L, XL or the LISA method using a thin catheter. The study randomly assigns infants to one of these two groups. The SALSA method is being compared to the LISA method, which is the active comparator. The procedures occur when infants qualify for surfactant therapy while on CPAP support in the NICU. During the study, researchers will monitor events like low heart rate and oxygen levels during the surfactant procedure. They will also track success rates of the procedure, need for intubation within 72 hours, number of attempts needed, and total days of breathing support up to 52 weeks. The study is expected to provide information on the safety and efficiency of the two surfactant delivery methods in premature infants.

Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants