Every year, 50,000 very low birth weight (VLBW, <1,500 g) infants are born in the U.S. The use of surfactant dramatically decreases morbidity and mortality due to respiratory distress syndrome (RDS) in VLBW infants. Current standards for surfactant administration require the infant to be intubated, so that surfactant can be delivered to the trachea and lungs. Intubating a VLBW infant is challenging and time consuming, and can lead to serious complications. There is an urgent need for less invasive ways to deliver surfactant, without endotracheal intubation (ETI). The purpose of this project is to develop a secure, effective, faster, and easily placed Surfactant Administration Airway for VLBW Infants (SAAVI). The SAAVI is designed for delivering surfactant to VLBW infants without ETI. It also serves as a rescue airway when the infant needs more ventilatory support. In the SAAVI design, there is an oral cavity balloon and an esophageal cuff, so that surfactant and air can be directed to the trachea via an oropharyngeal aperture. We have fabricated working prototypes and tested them successfully on mannequins and animals. Our long-term goal is to improve survival and decrease morbidity of VLBW infants through a device that is better, safer, and easier to use for surfactant delivery and airway rescue.
Our aims are to: (1) test the SAAVI for surfactant delivery and ventilation in a rabbit surfactant depletion model; and (2) finalize the SAAVI device in 2 sizes for VLBW infants weighing <1000 g, and 1000-1500 g. To determine the optimal dimensions for the SAAVI, we will obtain anatomical measurements from 70 fetuses at 24-34 weeks of gestation by ultrasound. In the animal study, 4-week old rabbits will be used as the model for testing and validating the SAAVI. The rabbits will be randomized to 14 2 groups -- 10 in the ETI group, and 10 in the SAAVI group. Surfactant will be labeled with C- DPPC, and will be administered via the ET tube or SAAVI. Surfactant delivery and distribution in the lungs will be measured by radioactivity. To assess efficacy of surfactant delivery and SAAVI as an airway, we will compare pulmonary function between the 2 groups. Completion of the aims will result in validated SAAVI devices of appropriate sizes, ready for human testing. As soon as the Phase I milestones are achieved, we will move quickly to commercialize the SAAVI by: (1) applying for Phase II funding for clinical trials; (2) starting the process for an 510 (k) submission to the FDA; and (3) approaching investors for funding commercialization.
Every year, 50,000 very low birth weight (VLBW, <1,500 g) infants require the surfactant therapy to prevent complications due to immature lungs. Surfactant is currently delivered to VLBW infants by an endotracheal tube -- but placing a tube in the trachea in small infants is invasive, difficult, and potentially injurious. In this proposal, we will develop a new secure, effective, faster, and easily placed device -- the Surfactant Administration Airway for VLBW Infants (SAAVI) -- to solve this problem.