Project Grant R41HD104409

BABYSTRONG TAVNS-PAIRED BOTTLEFEEDING 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 HYPOXIC ISCHEMIC BRAIN INJURY (HIE), WITH FEEDING DIFFICULTY. INDEPENDENT FEEDING IS CRITICAL FOR INFANTS TO BE DISCHARGED HOME WITH THEIR FAMILIES AND AVOID A GASTROSTOMY TUBE (G-TUBE) PLACEMENT. THE CURRENT STANDARD OF CARE FOR INFANTS WITH FEEDING DIFFICULTY INVOLVES EARLY OROMOTOR STIMULATION AND FEEDING WITH THERAPISTS ONCE DAILY FOR SAFE FEEDING. TECHNOLOGIES ON THE MARKET POSSESS DIAGNOSTIC CAPABILITIES THAT ALLOW CLINICIANS TO MONITOR FEEDING PARAMETERS, BUT NO TECHNOLOGIES ACTIVELY IMPROVE ORAL FEEDING FOR DISCHARGE. OUR TEAM PREVIOUSLY INITIATED A FIRST-IN-INFANTS PILOT STUDY IN WHICH WE PAIRED TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION (TAVNS) STIMULATION WITH BOTTLE FEEDING TO ENHANCE MOTOR LEARNING OF FEEDING IN PRETERM OR TERM HIE INFANTS, WHO WERE FAILING ORAL FEEDS. TAVNS IS A NON- INVASIVE FORM OF VAGUS NERVE STIMULATION, WHICH FACILITATES ACTIVITY-DEPENDENT NEUROPLASTICITY. DURING THIS PILOT TRIAL, OUR TEAM DEVELOPED CUSTOM OPEN AND CLOSED-LOOP TAVNS-PAIRED FEEDING SYSTEMS TO TEST INITIAL EFFICACY. PRELIMINARY DATA SHOWS NO SIGNIFICANT ADVERSE EFFECTS IN THE 27 PATIENTS TREATED WITH THIS NOVEL THERAPY. ALSO 50% OF INFANTS ACHIEVED FULL ORAL FEEDS IN 2 WEEKS WHEN THEY WOULD HAVE RECEIVED A G-TUBE. FOR FURTHER CLINICAL TRIAL TESTING AND COMMERCIALIZATION, WE NEED TO CREATE A LESS EXPENSIVE AND COMPACT SET-UP THAT IS EASIER TO USE. IN THIS PHASE I APPLICATION, WE PROPOSE THE DEVELOPMENT OF OUR BABYSTRONG TAVNS BOTTLE FEEDING SYSTEM, WITH SUBSEQUENT VALIDATION IN A SMALL-SCALE SAFETY AND EFFICACY STUDY. THE FINDINGS FROM THIS PROPOSAL WILL SUPPORT OUR HYPOTHESIS THAT TAVNS PAIRED FEEDINGS WILL IMPROVE DAILY FEEDING VOLUMES FOR THIS VULNERABLE POPULATION AND POSITION US FOR A PHASE II RANDOMIZED CONTROLLED TRIAL.