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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Thrive Neuromedical, LLC
Study ID
NCT06063122
Status
Recruiting
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Conditions

  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
32 Weeks - 35 Weeks
Healthy Volunteers
Accepted

Interventions

  • smallTalk NICU Active — DEVICE
    The novel smallTalk NICU Active product design allows a disposable pacifier (equipped with the smallTalk sensor) to act as an infant-controlled mechanism for administration of developmentally appropriate parental voice, delivered by the NICU-safe speaker contingent upon the infant suck strength meeting an individually calibrated threshold.

Study Details

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 Dates

Start date
Mar 8, 2024
Status verified
Sep 2025
Primary completion
Jan 31, 2026
Completion
Feb 1, 2026

Study Design

Enrollment
203 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Control Group: Non-contingent exposure to recorded mother's voice
    Participants will receive 20 minutes of non-contingent recorded mother' voice during two 20-minute sessions, with a maximum of 2 sessions per day. Recordings are played through the smallTalk speaker device in passive mode, which limits play time to 20-minute exactly and volume to 45 dB in the A-weighted scale as per American Academy of Pediatrics recommendations. For these sessions, the therapist will remain at bedside with the infant and the device, as if they were administering the intervention. Nurses do not typically remain at bedside for the procedure due to workload issues and the low risk of the intervention.
  • Experimental: Intervention Group: Contingent exposure to recorded mother's voice
    Participants will receive 20 minutes of contingent recorded mother' voice also at 45 dBA, during two 20-minute sessions, with a maximum of 2 sessions per day. The smallTalk Active system integrates a wireless, lightweight and sealed sensor unit that securely fits into a Philips NICU Soothie pacifier. The speaker device is factory set to communicate constantly with the sensor unit, and to only deliver a predetermined 10 seconds of recorded parent's voice upon detection of a suck that meets a pressure threshold, which is automatically set by the speaker device.

Primary Outcome Measure

Sensory processing measurement by ERP recording [ Time Frame: Initial ERP Test is performed 2 days prior to intervention. Intervention timeframe is 20 sessions across 3 weeks. ERP Test is repeated within 24 hours of the last session. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Nathalie Maitre, MD
[email protected]
404-785-2000
Thrive Neuromedical, LLCChagrin FallsOhio44023
Dean Koch
[email protected]
440-289-3656

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By research site
Emory University· Atlanta, GAThrive Neuromedical, LLC· Chagrin Falls, OH

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