Neoneur 921494 Improving High-Risk Infant care, From Hospital to Home with Neoneur Telehealth (4.21) The overall outcome for high-risk infants have improved significantly over the past two decades with increased long-term survival and less major morbidities. The focus has shifted to defining outcomes according to the quality of survival, with neurodevelopmental impairments being one of the hallmarks of both prematurity and major congenital anomalies. Feeding remains a major challenge for nursing care of high-risk infants, many who start life with a feeding tube. Poor feeding is the most common reason for delayed discharge. Safe oral feeding is a particular challenge for premature infants, and those born with complex congenital disorders, many of whom are fed via a nasogastric tube initially or during recovery after surgery. Unlike other critical physiological parameters currently there is no quantitative means to measure adequate infant maturation (for the preterm infant) or recovery (for the cardiac infant) to safely transition to oral feeding without respiratory risk. The Neoneur is a hand-held, mobile device, which uniquely (issued patents 8473219, 8413502) measures patterns of oral cavity pressure, synchronized with respiration providing the clinician with a quantitative assessment of feeding patterns. In 2019, Neoneur, LLC completed over 150 clinical interviews as part of the national I-Corps program (NSF 1844816). Based on these interviews we hypothesize Neoneur's measurements are biomarkers that will improve quality of care and transitions to oral feeding, and by enabling telehealth evaluation infants will get home earlier and decreases necessity for rehospitalization due to poor weight gain. The technical effort supported by this proposal will advance the capability of the Neoneur to provide the following: utility in the clinical setting, a means for remote telehealth evaluations, demonstrated correlation to clinical relevance in infant specific measurements and tracking, improve FDA application and claims, advance market adoption, and investor readiness. This Fast-Track SBIR proposes to transform a research into a clinically relevant device through the following aims. Phase l -upgrade prototype for manufacturability, - clinical cleanliness, and telehealth functionality: Phase II - scale manufacturing, and performing a study to assess safety and clinical value/utility. We will enroll 140 preterm infants and 140 infants with complex congenital heart disease and follow them from initiation of oral feeding in the hospital and continue in the home for a maximum total of 12 weeks.
Public Health Relevance Statement: Narrative Neoneur 921494 Improving High-Risk Infant care, From Hospital to Home with Neoneur Telehealth (4.21) The technical effort supported by this proposal will advance the capability of the Neoneur to provide the following: utility in the clinical setting, a means for remote telehealth evaluations, demonstrated correlation to clinical relevance in infant specific measurements and tracking, improve FDA application and claims, advance market adoption, and investor readiness.
Project Terms: Assessment tool; Assessment instrument; Innovation Corps; I-Corps; Heart Abnormalities; Cardiac Abnormalities; Cardiac Malformation; Cardiac defect; Heart Malformation; heart defect; individual patient; improved outcome; manufacturability; data warehouse; wireless communication; postoperative recovery; post-operative recovery; recovery after surgery; recovery following surgery; Home; Academy; Adoption; Award; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Clinical Trials; Decision Making; Deglutition; Swallowing; Feedback; Feeding behaviors; Ingestive Behavior; feeding-related behaviors; nutrient intake activity; Feeding Patterns; Foundations; Gestational Age; Chronologic Fetal Maturity; Fetal Age; Goals; Grant; Hand; Hospitals; Infant; Infant Care; baby care; infant health care; infant healthcare; newborn care; Premature Infant; infants born premature; infants born prematurely; premature baby; premature infant human; preterm baby; preterm infant; preterm infant human; Interview; Morbidity - disease rate; Morbidity; Nipples; Nursing Care; Care given by nurses; Parents; Patents; Legal patent; Patients; Pediatrics; Pennsylvania; pressure; Production; Scientific Publication; Publications; Research; respiratory mechanism; Respiration; Risk; Safety; Survey Instrument; Surveys; Testing; Universities; Weight Gain; Weight Increase; body weight gain; body weight increase; wt gain; Work; Measures; Infection Control; Enteral Feeding; enteric feeding; feeding tube; gastric feeding; tube feeding; congenital heart disorder; congenital cardiac abnormality; congenital cardiac disease; congenital cardiac disorder; congenital cardiac malformation; congenital heart abnormality; congenital heart anomaly; congenital heart disease; congenital heart malformation; Tube; base; improved; Clinical; premature; prematurity; Phase; Physiological; Physiologic; Link; Evaluation; Buccal Cavity; Buccal Cavity Head and Neck; Cavitas Oris; Mouth; Oral cavity; pediatric; Childhood; sucking; Recovery; Congenital Disorders; Opiates; Opioid; Measurement; Funding; Dysfunction; Physiopathology; pathophysiology; Functional disorder; tool; Life; programs; vulnerable infant; high risk infant; Complex; Oral; Pattern; respiratory; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; interest; American; Performance; success; hospital re-admission; re-admission; re-hospitalization; readmission; rehospitalization; hospital readmission; Nutrient; skills; Modality; Devices; QOC; Quality of Care; Intervention Strategies; interventional strategy; Intervention; Documentation; feeding schedule; Preparedness; Readiness; telehealth; Data; Clinical Nursing; Enrollment; enroll; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Process; Cardiac; Development; developmental; feeding; design; designing; Neurodevelopmental Impairment; Outcome; innovation; innovate; innovative; Impairment; clinically relevant; clinical relevance; handheld mobile device; mobile device; usability; iterative design; prototype; population based; Biological Markers; bio-markers; biologic marker; biomarker; clinical decision-making; congenital anomaly
