Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Recruiting now · Not applicable
Conditions studied: Premature Birth
In brief
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.
Key facts
- Study ID
- NCT06063122
- Run by
- Thrive Neuromedical, LLC
- People needed
- 203
- Starts
- 2024-03-08
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-09-10
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth
You may not qualify if…
- 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.
Where it is running
- Emory University — Atlanta, Georgia, United States (enrolling)
- Thrive Neuromedical, LLC — Chagrin Falls, Ohio, United States
Full record on ClinicalTrials.gov
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