Phase I Amount
$1,191,469
Thrive Neuromedical LLC proposes to develop, test, and gain FDA clearance to market a therapeutic device to improve speech sound differentiation in preterm infants hospitalized in the neonatal intensive care unit (NICU). During this project we will complete development of the smallTalk NICU Active system and conduct a clinical trial to prove its efficacy in improving speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Prototype research and development met or exceeded the stated technical milestones. In 2020, preterm birth affected 1 of every 10 infants born in the United States. Large numbers of infants are born daily requiring NICU stays. This NICU stay, while medically necessary, can result in impairments in the developing infant brain. In particular, there is a lack of exposure to infant directed parental or caretaker voice. It is known that exposure to infant directed speech, which is different from adult directed speech, is developmentally important for optimal, early brain development. The ability to differentiate speech sounds is a prerequisite for developing more complex receptive language. Infant directed speech, ideally when sought by an attentive infant, stimulates brain wiring and attunes the infant's brain to speech sounds. For the developing infant brain, "plasticity" for language learning peaks during infancy, as the baby develops neural connections that enable differentiating their native language's speech sounds. These connections are the foundation for more complex brain functions. Due in part to their time in NICU care, preterm infants have poorer receptive language scores at age two. A majority require speech and language intervention prior to school age. There is currently no intervention that addresses the problem of poor speech sound differentiation arising from NICU hospitalization, a period when the greatest potential for improving outcomes exists. This proposal seeks funding for the final product development and rigorous testing of the smallTalk NICU Active system. We will manufacture a small batch of the devices to support a proposed randomized clinical study at Emory University, the results of which will be submitted to FDA for clearance to market the innovative device.
Public Health Relevance Statement: PROJECT NARRATIVE Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes. The result of this proposal will be a fully developed clinical device ready for submission to FDA for clearance, utilizing caregiver recorded infant-directed speech as the first intervention specifically designed for preterm infants and their brain development.
Project Terms: 21+ years old; Adult Human; adulthood; Adult; Affect; ages; Age; Auditory Perception; hearing perception; sound perception; Birth; Parturition; Brain; Brain Nervous System; Encephalon; Calibration; Child; 0-11 years old; Child Youth; Children (0-21); kids; youngster; Clinical Research; Clinical Study; Clinical Trials; Cognition; Economics; economic; Electroencephalography; EEG; Electroencephalogram; Environment; Family; Foundations; Geography; Hearing; Hospitalization; Hospital Admission; Hospitals; Human; Modern Man; Incubators; Infant; Newborn Infant; 0-4 weeks old; Newborns; newborn child; newborn children; Premature Infant; infants born premature; infants born prematurely; premature baby; premature infant human; preterm baby; preterm infant; preterm infant human; Neonatal Intensive Care Units; Newborn Intensive Care Units; neonatal ICU; Justice; Language; Language Delays; Language Development; acquiring language skills; language acquisition; language learning; Learning; Marketing; Mothers; Noise; Nurses; nurse; Team Nursing; Pacifiers; Parents; parent; Pregnancy; Gestation; pressure; Reading; Recommendation; Research; research and development; Development and Research; R & D; R&D; Safety; sound; Speech; Speech Sound; Technology; Testing; Time; United States; Universities; Uterus; womb; Voice; Measures; Care Givers; Caregivers; Infection Control; Developmental Delay; Specific Child Development Disorders; Developmental Delay Disorders; measurable outcome; outcome measurement; Outcome Measure; Schedule; Caring; Prematurely delivering; Preterm Birth; premature childbirth; premature delivery; preterm delivery; Premature Birth; auditory stimulus; Loudness; sensor; improved; Clinical; prematurity; premature; Phase; Physiologic; Physiological; psychological; psychologic; Ensure; infantile; infancy; sucking; Stimulus; awake; school age; School-Age Population; Policies; Measurement; Cooperative Learning; Experiential Learning; Active Learning; Funding; randomized control trial; Randomized, Controlled Trials; Therapeutic; Exposure to; Auditory; Complex; Protocols documentation; Protocol; Pattern; System; Auditory system; experience; early childhood; neural; Structure; peer; empowerment; Devices; social; neural circuit; neural circuitry; neurocircuitry; synaptic circuit; synaptic circuitry; medically necessary care; medically necessary; response; Intervention; Intervention Strategies; interventional strategy; behavioral assessment; Behavior assessment; Address; brain based; Data; Randomized; randomisation; randomization; randomly assigned; Cognitive; Process; Development; developmental; designing; design; Outcome; Population; innovate; innovative; innovation; 2 years of age; age 2 years; aged 2 years; aged two years; two year old; two years of age; 2 year old; Impairment; language processing; prototype; high risk; effective intervention; standard treatment; standard care; intervention effect; product development; clinical practice; social health determinants; targeted drug therapy; targeted drug treatments; targeted therapeutic; targeted therapeutic agents; targeted therapy; targeted treatment; cognitive development; family support; improved outcome; neuro-sensory; neurosensory; auditory processing; infection risk; language outcome; health determinants; verbal; manufacture
