Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants

Recruiting N/A Interventional Study
Premature Birth
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
32 Weeks – 35 Weeks
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
203 (estimated)
Sponsor
Thrive Neuromedical, LLC · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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…
Contacts

Dean Koch

440-289-3656

dean@smalltalk.tech

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