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NCT06063122 · ClinicalTrials.gov registry record · NA
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
A NA study of Premature Birth, sponsored by Thrive Neuromedical.
- Recruiting
- Registry status
- NA
- Development phase
- 203
- Enrollment target
- 2
- Study locations
NCT06063122 is a NA study of Premature Birth that is actively recruiting participants, run by Thrive Neuromedical. The registered enrollment target is 203 participants, below the 389-participant average among 38 other Premature Birth trials with a reported enrollment target (48% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06063122, a NA study of Premature Birth, is actively recruiting participants, sponsored by Thrive Neuromedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 203 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 389-participant average among 38 other Premature Birth trials with a reported enrollment target (48% lower). The listed sponsor is Thrive Neuromedical, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT06063122 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, Ohio.
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.
What interventions are being tested in trial NCT06063122?
The interventions under investigation include: smallTalk NICU Active (DEVICE).
Who is sponsoring clinical trial NCT06063122?
This trial is sponsored by Thrive Neuromedical, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.