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.
CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth
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.
Parallel
smallTalk NICU Active
DeviceThe 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.
Sensory processing measurement by ERP recording
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 a computer-generated woman's voicing one of six syllables (/ba/, /da/, /ga/, /bu/, /du/, /gu/) randomly and at random intertrial intervals for a total of 25 trials per syllables over 7-10 minutes. Inter-trial intervals will be varied between 1600ms and 2600ms. All stimuli are presented thus to prevent habituation.
Intervention effect size impact by NICU background noise
We will test whether the effect size of the between-treatment-group, pretest-adjusted effect will vary by amount of background noise, favoring lower background noise. During each session, a sound level meter will record sound amplitude exposure at the baby's head. Sound levels will be logged onto a built-in SD card at 15 min intervals and downloaded after a 24-hour period. Measurements will occur every 3 days. Average sound exposure will be calculated from all measurements over the course of the intervention.
Intervention effect size by NICU room type (private or semi-private/open bay)
This aim is only exploratory and will investigate the possibility that the between-treatment-group, pretest-adjusted effect size will vary by the room setting in which mother's voice exposure occurred.
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Thrive Neuromedical, LLC
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Emory University
Collaborator
