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Study identifier: NCT06063122 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Premature Birth  ·  Sponsor: Thrive Neuromedical, LLC

PhaseNA
Planned participants203
Who can joinAll sexes, 32 Weeks to 35 Weeks
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Dean Koch  ·  440-289-3656  ·  dean@smalltalk.tech

Always discuss trial participation with your own doctor first.

Locations (2)

Emory UniversityAtlanta, Georgia, United StatesRecruiting
Thrive Neuromedical, LLCChagrin Falls, Ohio, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06063122