Actively Recruiting
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Led by Thrive Neuromedical, LLC · Updated on 2025-09-10
203
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
Sponsors
T
Thrive Neuromedical, LLC
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Corrected gestational age between 32 0/7 and 35 0/7 weeks at study start
- Gestational age at birth between 32 0/7 and 35 0/7 weeks
You will not qualify if you...
- Ventilation using an endotracheal tube
- Major congenital malformations
- Family history of genetic hearing loss
- Use of sedative or seizure medications that may affect sensory processing
- Severe white matter injury increasing risk of hearing deficits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Thrive Neuromedical, LLC
Chagrin Falls, Ohio, United States, 44023
Not Yet Recruiting
Research Team
D
Dean Koch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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