Thrive Neuromedical, LLC — Department of Health and Human Services SBIR Phase I: NIDCD

Description

PROJECT SUMMARY Approximatelyinfants are born preterm annually in the USThese babies have rates of developmental problems significantly greater than term infants from early childhood to school ageWhile Neonatal Intensive Care UnitNICUhospitalization is necessary for these babiesthe NICU itself can also be a major contributor to delays or impairmentThe 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 dependentWith low visitation rates due to socioeconomic and other factorsNICU infants have deficiencies in infant directed speechwhich is associated with poorer differentiation of speech sounds at dischargealtered brain structure and worse language outcomes at two years of ageThe goal of the proposed project is to supplement caregiver visitation and address the need for an intervention using caregiversvoice that can be safely administered regularly in the NICU during critical periods of sensory developmenteven when the infant s caregiver cannot be presentIt also offers the option to promote active learning of speech soundsbeyond a simple passive exposure to caregiver voiceThe system builds on the currently IP protected deviceNICU safe speaker systemby adding an option to support infants in directing their own exposure to their parentsvoicesensor equipped wirelessly connected pacifierStrong evidence supports the effectiveness of contingent exposureinfant must exert an action to obtain soundto caregiver speech as a key concept in learning languageStudies have shown thatainfant acquisition of early speech sounds is essential to building later receptive language abilitiesbmother s voice is a preferred voice and can be distinguished early in life from other soundsandclearning of language in infants is improved when language exposure is presented contingent on infant action and promptly after the actionThis precept holds true even in early pre language phaseswhen infants are still differentiating among speech soundsThereforewe designed a device that allows preterm infantsactive sucking on a pacifier as the behavior that activates an audio recording of caregiver s voice less than asec after the suckCaregiver s voice provides the critical auditory input needed to learn speech soundsThis approach enables caregivers to participate in their infant s health and developmenteven when they cannot be presentIn Aimwe will demonstrate manufacturing feasibility of the pacifier deviceand develop and incorporate a tablet computerappthat allows real time monitoring and adjustment of infant suck thresholds by nurse or therapistIn Aimwe will demonstrate that the device accurately measures and wirelessly communicates pacifiersuckpressure readings to the NICU safe speakerwhich delivers caregiver voice contingent on the infant suck actionand the tablet computerappand also assess the product classification and requirements by FDA for marketing NARRATIVE The approximatelypreterm infants born annually in the US are at high risk for neurosensory impairments and developmental delaysSpecificallyinfants in NICU are deprived of infant directed speech soundsdue to low parental visitation rates and the noisy hospital environmentresulting in poorer differentiation of speech sounds at dischargealtered brain structure and worse language outcomesThe goal of the proposed project is to address these deficiencies by bringing recorded infant directed speech into the incubator through an activecontingent delivery system