Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants - Trial NCT06063122

Timeline & Enrollment

Primary Outcome

Sensory processing measurement by ERP recording

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.

ICD-10 Classifications