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Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
NCT06063122 · View on ClinicalTrials.gov ↗
Study 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 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 Studied
Interventions
- DEVICE smallTalk NICU Active
Study Locations (2)
Georgia
- Emory University — Atlanta
Ohio
- Thrive Neuromedical, LLC — Chagrin Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2024-03-08 |
| Est. Completion | 2026-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06063122
The ClinicalTrials.gov registry entry for NCT06063122 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thrive Neuromedical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Premature Birth appearing as the primary indexed condition, and to 1 intervention — of which smallTalk NICU Active is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06063122 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Georgia, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06063122 about?
NCT06063122 is a clinical study titled "Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants". 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...
What is the current status of trial NCT06063122?
This trial is currently recruiting. It is a NA study. The enrollment target is 203 participants. The study started on 2024-03-08. Estimated completion is 2026-02-01.
What conditions does trial NCT06063122 study?
This clinical trial studies the following conditions: Premature Birth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06063122?
The interventions under investigation include: smallTalk NICU Active (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06063122?
This trial is sponsored by Thrive Neuromedical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06063122 being conducted?
This trial has 2 study locations across Georgia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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