BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding

Project Summary The long-term goal of this project proposal is to develop and commercialize a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed. Independent feeding is critical for infants to be discharged home with their families and avoid placemen of a gastrostomy tube (G-tube) for direct stomach feeding. The current standard of care for infants with feeding difficulty involves early oromotor stimulation and feeding practice with therapists who guide safe feeding. Few other therapies exist for infants who are not making progress with feeding volumes at term age. Technologies currently on the market are used to stimulate early sucking patterns at 31-32 weeks gestational age with a puff of air, but do not work to stimulate active feeding in older infants. Other technology monitor parameters, such as suck amplitude, but no technologies actively improve oral feeding in older infants whose main reason for continued hospitalization is feeding delays. To tackle this problem, we took the novel approach of pairing a non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) stimulation with bottle feeding. In these first-in-infant open-label pilot studies 54% of infants in discussions for G-tube placement for feeding delay, reached full feeds within 2 weeks, and even infants who did not achieve full feeds improved their po feeding volumes. Further, infants who got to full feeds showed stronger and more complex circuits associated with motor skills, suggesting neuroplasticity associated with the activity of taVNS-paired with feeding. During the phase I STTR award period, our team moved from a complex system of electronic pulse generators and computers to a handheld taVNS device, and a slimmed down, custom ear electrode targeting the auricular branch of the vagus nerve at the tragus. We customized and refined the taVNS unit operation and worked with manufacturers to make it specifically fit the needs of our infants. We obtained advice and feedback from our parent and therapist advisors in deciding on a product. With this compact set-up that is easier to use, we are ready to test the BabySTrong feeding system in a multicenter, randomized, controlled, blinded trial to show efficacy in improving the daily feeding volumes, the days to full oral feeds, the number of infants who avoid G-tube placement and increased neuroplasticity in white matter circuits. If this groundbreaking new approach to infant feeding is successful, we may impact length of stay and associated hospital costs, and address family and care provider frustration inherent with continued hospitalizations for feeding delays. With positive results from this phase II trial, we hope to move the vision of feeding delay treatment to one of taVNS facilitating activity- dependent neuroplasticity and feeding competence. The findings from this proposal will support our FDA application and commercialization plans for the BabySTrong system.