Status:
RECRUITING
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Lead Sponsor:
Thrive Neuromedical, LLC
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Emory University
Conditions:
Premature Birth
Eligibility:
All Genders
32-35 years
Phase:
NA
Brief 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 ...
Detailed 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 del...
Eligibility Criteria
Inclusion
- CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth
Exclusion
- 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.
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT06063122
Start Date
March 8 2024
End Date
February 1 2026
Last Update
September 10 2025
Active Locations (2)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Thrive Neuromedical, LLC
Chagrin Falls, Ohio, United States, 44023