C. Bernstein
BB Medical Surgical,
United States
Keywords: lung development, rescue airway, surfactant, first responder
Summary:
Respiratory Distress Syndrome is a leading cause of morbidity and mortality in preterm infants, but manageable with surfactant delivery. Current methods, including the LISA (Less Invasive Surfactant Administration), INSURE (Intubation-Surfactant-Extubation), and the emerging SALSA (Surfactant Administration through Laryngeal Supraglottic Airway) techniques, are technically challenging, require advanced clinical expertise, and may not be feasible in resource-limited settings. To address these limitations, we propose SAAVI (Surfactant Administration Airway for Very low birth weight Infants), an innovative, user-friendly, and cost-effective device designed to facilitate surfactant administration by ensuring effectiveness and reducing operator dependency. We leveraged our engineering expertise to iteratively optimize the design of existing prototypes of SAAVI, to enable the IDE submission and clinical trials. We finalized the SAAVI design for 2 cohorts: < 1 kg (≤ 26 week Gestational Age) and 1-1.5 (>26 - 30 week Gestational Age) babies. We propose in our Phase 2 STTR application a human usability study with neonatal healthcare providers to compare SAAVI to the current standard techniques (LISA and INSURE). Participants will include clinicians with varying levels of expertise, ensuring representation from both high-resource and low-resource settings. Key metrics will include time to complete the procedure, user satisfaction, and error rates. The insights gained will guide further refinements to enhance the device’s usability and scalability. SAAVI has the potential to transform the delivery of surfactant therapy for neonatal RDS, addressing critical limitations of current techniques. By improving ease of use, accessibility, and safety, this device could reduce disparities in neonatal care globally and improve outcomes for preterm infants. We also received a Phase 1 SBIR from the US Air Force AFWERX program to develop SAAVI prototypes for use as a rescue airway, investigating the methods and materials we adopted to fabricate the pediatric surfactant delivery devices described above. We are hopeful that such a rescue device can enable buddy rescue, making it simple for a first responder to maintain a patent airway even in challenging environments. The devices can be placed in less than 30 seconds, and do not require a laryngoscope, making them usable by lay people and clinicians with less training in emergent airway response. Thank you for your consideration.