Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Thrive Neuromedical, LLC · with National Institute on Deafness and Other Communication Disorders (NIDCD), Emory University · NCT06063122
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 7 mo–8 mo · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 203
- US sites recruiting
- 1
- Study start
- March 8, 2024
- Record last updated
- September 10, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: smallTalk NICU Active
Conditions: Premature Birth
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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 ERP measured sensory processing) and severe white matter injury as it increases the likelihood of hearing deficits.
Recruiting US locations
Emory University
Atlanta, GA 30322
Site contact: Nathalie Maitre, MD · 404-785-2000 · nathalie.linda.maitre@emory.edu
Study contacts (from the official record)
- Dean Koch · 440-289-3656 · dean@smalltalk.tech
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