Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Premature Birth, sponsored by Thrive Neuromedical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A high-density array of 128 electrodes embedded in soft sponges (high-density 64-electrode waveguard™ net, ANT Neuro, Hengelo, Netherlands) will be used to record ERPs with a sampling rate of 1000 Hz, filters set to 0.1-400 Hz. Recording of brainwaves will be controlled by eego™mylab system (v. 9.2, ANT Neuro, Hengelo, Netherlands). E-Prime (v. 4.0, PST, Inc., Pittsburgh, PA) software will control stimulus delivery. The stimuli will be presented at 60 dBA. The ERP speech sound paradigm included
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 |
What NCT06063122 shows while recruiting
NCT06063122 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 389-participant average among 38 other Premature Birth trials with a reported enrollment target (48% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Premature Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06063122's enrollment target sits among peer trials
203 13th of 38 higher than 26 of 38 other Premature Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Premature Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants
RECRUITING · NA
-
Optimizing Family Counseling for Anticipated Extremely Preterm Delivery
RECRUITING · NA
-
The Periviable GOALS Decision Support Tool
RECRUITING · NA
-
Postpartum Care in the NICU (PeliCaN) Transitions
RECRUITING · NA
-
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
RECRUITING · NA
-
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05652686 · 203 participants · Phase 1
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
- NCT07031245 · 203 participants · NA
Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout
- NCT03481010 · 204 participants · NA
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
- NCT04249830 · 204 participants · NA
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI