RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-08
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06063122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:32 Weeks to 35 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth
  1. * 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.

Contacts and Locations

Study Contact

Dean Koch
CONTACT
440-289-3656
dean@smalltalk.tech

Principal Investigator

Dean Koch
PRINCIPAL_INVESTIGATOR
Thrive Neuromedical, LLC

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
Thrive Neuromedical, LLC
Chagrin Falls, Ohio, 44023
United States

Collaborators and Investigators

Sponsor: Thrive Neuromedical, LLC

  • Dean Koch, PRINCIPAL_INVESTIGATOR, Thrive Neuromedical, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

  • preterm
  • premature
  • NICU
  • neonatal

Additional Relevant MeSH Terms

  • Premature Birth