Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Thrive Neuromedical, LLC
Summary
The goal of this clinical study is to test a new, novel medical device designed to improve 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. 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 study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure/timing, connected to a speaker that delivers mother's voice. The study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device.
Description
Every year in the United States, approximately 10% of infants are born preterm, impacting nearly 400,000 families in the US alone. These infants often experience significant cognitive and language delays in early childhood, with negative implications on social and academic function at school age and beyond. Complex higher-order functions, such as language, build on early, more basic neural processes that lay the foundation for later connections and systems. A fundamental neural processing function necessary for the development of cognition and receptive language is the early ability to differe…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth Exclusion Criteria: * Ventilation using an endotracheal tube, major congenital malformations, family history of genetic hearing loss, and use of sedative/seizure medications (medications potentially masking ERP measured sensory processing) and severe white matter injury as it increases the likelihood of hearing deficits.
Interventions
- DevicesmallTalk NICU Active
The novel smallTalk NICU Active product design allows a disposable pacifier (equipped with the smallTalk sensor) to act as an infant-controlled mechanism for administration of developmentally appropriate parental voice, delivered by the NICU-safe speaker contingent upon the infant suck strength meeting an individually calibrated threshold.
Locations (2)
- Emory UniversityAtlanta, Georgia
- Thrive Neuromedical, LLCChagrin Falls, Ohio