A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates / Aerosurf

Background

Babies that are born before 37 weeks of gestation are considered premature. Depending on the exact age of gestation, babies may have various levels of underdevelopment. Often times babies born preterm, especially before 35 weeks, have difficulty breathing and fully expanding their lungs after birth. Term babies produce surfactant naturally. Surfactant is a soapy substance in the lungs that allows the lungs to expand properly. Some premature babies may lack surfactant in their lungs, and may require administration of synthetic or animal surfactant.  Babies are currently given surfactant via a tube inserted in the windpipe. Some babies will be will have this tube inserted just for administration of surfactant. Insertion of the tube carries some risks. 

Purpose

Since insertion of endotracheal tube carries risks, in this study surfactant is aerosolize - making it a vapor that the baby can breathe in through the nose. By providing the surfactant in aerosol form we hope to avoid intubations done to administer liquid surfactant. 

Read more about this study at clinicaltrials.gov

Who to contact if you want more information

The Research Team will be contacting you regarding your interest in this study. 

You may also contact the Sharp Mary Birch Neonatal Intensive Care Unit (NICU) at: 858 939-4298, or NICU Research Offices at:  858 939-4112