SBIR-STTR Award

Approximately 400,000 infants are born preterm annually in the US. These babies have rates of developmental problems significantly greater than term infants from early childhood to school age. While Neonatal Intensive Care Unit (NICU) hospitalization is necessary for these babies, the NICU itself can also be a major contributor to delays or impairment. The atypical sensory environment NICU infants experience during this sensitive period of brain development can alter the construction of sensory systems upon which higher order functions are dependent. With low visitation rates due to socioeconomic and other factors, NICU infants have deficiencies in infant-directed speech, which is associated with poorer differentiation of speech sounds at discharge, altered brain structure and worse language outcomes at two years of age. The goal of the proposed project is to supplement caregiver visitation and address the need for an intervention using caregivers’ voice that can be safely administered regularly in the NICU during critical periods of sensory development, even when the infant’s caregiver cannot be present. It also offers the option to promote active learning of speech sounds, beyond a simple passive exposure to caregiver voice. The system builds on the currently IP-protected device (NICU safe speaker system) by adding an option to support infants in directing their own exposure to their parents’ voice (sensor equipped wirelessly connected pacifier). Strong evidence supports the effectiveness of contingent exposure (infant must exert an action to obtain sound) to caregiver speech as a key concept in learning language. Studies have shown that (a) infant acquisition of early speech sounds is essential to building later receptive language abilities; (b) mother’s voice is a preferred voice and can be distinguished early in life from other sounds; and (c) learning of language in infants is improved when language exposure is presented contingent on infant action and promptly after the action. This precept holds true even in early pre-language phases, when infants are still differentiating among speech sounds. Therefore, we designed a device that allows preterm infants’ active sucking on a pacifier as the behavior that activates an audio recording of caregiver’s voice less than a 1 sec after the suck. Caregiver’s voice provides the critical auditory input needed to learn speech sounds. This approach enables caregivers to participate in their infant’s health and development, even when they cannot be present. In Aim 1, we will demonstrate manufacturing feasibility of the pacifier device, and develop and incorporate a tablet-computer “app” that allows real time monitoring and adjustment of infant suck thresholds by nurse or therapist. In Aim 2, we will demonstrate that the device accurately measures and wirelessly communicates pacifier “suck” pressure readings to the NICU safe speaker (which delivers caregiver voice contingent on the infant suck action) and the tablet-computer “app” and also assess the product classification and requirements by FDA for marketing.

Public Health Relevance Statement:
NARRATIVE The approximately 400,000 preterm infants born annually in the US are at high risk for neurosensory impairments and developmental delays. Specifically, infants in NICU are deprived of infant directed speech sounds, due to low parental visitation rates and the noisy hospital environment, resulting in poorer differentiation of speech sounds at discharge, altered brain structure and worse language outcomes. The goal of the proposed project is to address these deficiencies by bringing recorded infant directed speech into the incubator through an active, contingent delivery system.

Project Terms:
2 year old; Active Learning; Address; Age; Air; Auditory; auditory processing; base; Behavior; Brain; Caregivers; Child Rearing; Classification; compare effectiveness; critical period; design; Development; Developmental Delay Disorders; Devices; early childhood; Effectiveness; Electronics; Environment; Event-Related Potentials; evidence base; experience; Exposure to; Feedback; Funding; Goals; Health Professional; high risk; Hospitalization; Hospitals; Housing; Impairment; improved; Incubators; Infant; Infant Health; innovation; Intervention; Language; Language Delays; Language Development; language outcome; Learning; Length of Stay; Life; light weight; Marketing; Measures; Medical; Medical Device Designs; Methodology; Mothers; Neonatal Intensive Care Units; neurosensory; new technology; novel; Nurses; Outcome Measure; Pacifiers; Parents; Pediatric Hospitals; Performance; Phase; Premature Infant; pressure; primary outcome; Process; Production; prototype; psychologic; Reading; real time monitoring; Research; Research Institute; School-Age Population; Schools; seal; secondary outcome; Secure; sensor; Sensory; Sensory Deprivation; sensory system; socioeconomics; sound; Speech; Speech Delay; Speech Sound; standard of care; Structure; sucking; Support System; System; Tablet Computer; Tablets; Testing; Therapeutic; Time; Voice; wireless fi