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โ† Trials
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Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants

RecruitingNAAges 32 Weeks - 35 WeeksAllThrive Neuromedical, LLC
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In plain words

What the trial is, and whether it could suit you

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 speak

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • smallTalk NICU Active
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Where

2 sites
Emory University
Atlanta, United States
Thrive Neuromedical, LLC
Chagrin Falls, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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