Therapeutic Speech Device for Premature Birth

Recruiting at 1 trial location

Overseen By Dean Koch

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Thrive Neuromedical, LLC

Must not be taking: Sedatives, Seizure medications

Disqualifiers: Ventilation, Congenital malformations, Genetic hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

203 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, smallTalk NICU Active, designed to help premature babies in the NICU better recognize speech sounds. The device uses a pacifier with sensors that play a recording of the mother's voice when the baby sucks on it. Researchers aim to determine if this method helps babies distinguish speech sounds more effectively than simply hearing the voice without sucking. Babies born preterm and not on a breathing tube might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance speech recognition in premature infants.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but it excludes those using sedative or seizure medications.

What prior data suggests that this therapeutic speech device is safe for preterm infants?

Research shows that the smallTalk NICU Active device aids preterm infants by playing a recording of their mother's voice in response to the baby's sucking patterns. Currently, specific safety data from past studies on this device is unavailable. However, its classification in the "Not Applicable" phase indicates ongoing evaluation for initial safety and effectiveness.

Devices reaching this stage have typically undergone basic safety assessments, suggesting they are generally safe for testing in controlled settings. The smallTalk device, like other NICU equipment, is lightweight and designed for the safety of delicate infants. Although the study lacks detailed safety data, similar devices are usually tested to ensure they do not harm infants.

In summary, despite the absence of specific safety data, the device is intended to be safe for use with newborns in a clinical setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Therapeutic Speech Device for Premature Birth because it offers a novel approach to improving developmental outcomes in premature infants. Unlike other treatments that might rely on general auditory stimulation or non-specific environmental sounds, this method uses a personalized, contingent delivery of a recorded mother's voice. The smallTalk Active system is particularly noteworthy for its integration with a pacifier sensor that triggers the voice playback only when the infant sucks with enough pressure. This targeted interaction aims to encourage natural sucking behaviors and strengthen the bond between mother and infant, potentially leading to better long-term developmental benefits.

What evidence suggests that this device is effective for improving speech sound differentiation in preterm infants?

Research has shown that the smallTalk NICU Active device might help premature babies better recognize speech sounds. In this trial, participants in the intervention group will use a pacifier with a sensor that plays a recording of the mother's voice each time the baby sucks, helping the baby learn to differentiate speech sounds. This approach builds on findings that premature babies benefit from hearing their caregiver's voice, which can support brain development. Initial results suggest that this device may positively impact language development by actively engaging the babies in learning. Meanwhile, the control group will receive non-contingent exposure to the recorded mother's voice, allowing for a comparison of outcomes between the two groups. ^{1 2 3 4 6}

Who Is on the Research Team?

Dean Koch

Principal Investigator

Thrive Neuromedical, LLC

Are You a Good Fit for This Trial?

This trial is for preterm infants born at a gestational age of 35 weeks or more, currently aged between 32 and almost 36 weeks. It's not suitable for those with severe white matter injury, on ventilation via an endotracheal tube, taking sedative/seizure meds, with major congenital malformations or genetic hearing loss in the family.

Inclusion Criteria

My pregnancy was between 32 and 35 weeks at the start of the study and gave birth at 35 weeks.

Exclusion Criteria

My family has a history of genetic hearing loss.

You need a breathing tube to help with your breathing.

I have severe brain damage that could affect my hearing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive contingent or non-contingent recorded mother's voice intervention using a pacifier with a sensor and speaker device

3 weeks

20 sessions

Follow-up

Participants are monitored for safety and effectiveness after intervention using EEG and ERP recordings

Within 24 hours of the last session

What Are the Treatments Tested in This Trial?

Interventions

• smallTalk NICU Active

Trial Overview The study tests a new device that helps preterm infants differentiate speech sounds by using a pacifier sensor connected to a speaker delivering their mother's voice. The effectiveness will be measured through EEG response differences.

How Is the Trial Designed?

Group I: Intervention Group: Contingent exposure to recorded mother's voice Experimental Treatment 1 Intervention

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.

Group II: Control Group: Non-contingent exposure to recorded mother's voice Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Thrive Neuromedical, LLC

Lead Sponsor

Trials

1

Recruited

200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

The newly developed apparatus successfully identified apneic events and administered vibrotactile stimulation (VTS) with 100% accuracy in a simulated environment, indicating its potential effectiveness for treating neonatal apnea.

This device offers a noninvasive alternative to traditional nursing hand stimulation, suggesting it could improve the quality of care for neonates experiencing apnea, although it has yet to be tested on actual neonatal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized system to diagnose and treat neonatal apnea using vibrotactile stimulation. Faille, EO., Setya, A., Eisenfeld, L.[2013]

A new noninvasive technology called the actifier was successfully used to assess oromotor activity in preterm infants, which has been challenging due to their delicate health.

The study revealed a significant developmental trend in the early component of the perioral reflex during non-nutritive sucking, indicating that this method can provide valuable insights into the oromotor system of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanically evoked perioral reflexes in premature and term human infants. Barlow, SM., Dusick, A., Finan, DS., et al.[2019]

A new portable vibrotactile device has been developed to help premature infants interrupt central apnea by providing tactile stimulation to their foot, which may help restart their breathing.

Preliminary results indicate that the device effectively stimulates the nervous system, but further testing is needed to confirm its safety and effectiveness before it can be used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foot vibrotactile device for central apnea interruption in premature infants. Marayong, P., Mostoufi, MS.[2009]

A new low-cost device was developed to measure intraoral and expression pressures in premature infants, allowing for accurate assessment of their non-nutritive sucking skills.

Using this device, researchers collected data from 137 premature infants and successfully predicted which infants would achieve full oral feeding several weeks before hospital discharge, demonstrating its potential for monitoring feeding abilities in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Feeding Conditions of Premature Infants Through Non-Nutritive Sucking Skills Using a Sensitized Pacifier. Akbarzadeh, S., Lyu, T., Farhoodi, R., et al.[2022]

The engineering team developed a specialized breathing device aimed at improving respiratory support for premature babies, particularly in low-resource healthcare environments.

This device addresses critical health challenges faced by premature infants, potentially enhancing their survival rates and overall health outcomes in settings where advanced medical equipment is often unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools To Reduce Newborn Deaths In Africa. Richards-Kortum, RR.[2018]

In a study of 101 infants (69 preterm and 32 term) in the NICU, perinatal issues like gentamicin use and mechanical ventilation were found to significantly affect auditory brainstem response (ABR) in preterm infants, indicating potential auditory pathway impairments.

Gentamicin use was linked to increased latency of wave I, while mechanical ventilation decreased latencies of wave V and intervals in preterm infants, suggesting that these interventions can impact auditory development in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Brainstem Response in Preterm Infants in the Neonatal Intensive Care Unit. Raposo, D., Orfão, J., Menezes, M., et al.[2021]

Preterm infants in the NICU received only 13% of their time in care activities, with over 75% of that time dedicated to developmental care, highlighting the limited but crucial nature of these interactions.

Speech exposure was significantly higher during care activities, particularly when family members intentionally engaged with the infants, suggesting that enhancing family participation could provide important stimulation for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing speech exposure in the NICU: Implications for speech enrichment for preterm infants. Scala, ML., Marchman, VA., Godenzi, C., et al.[2021]

The actifier is a new device designed to stimulate intraoral tissues in neonates, featuring a wide frequency range and the ability to record muscle activity during sucking.

This device allows researchers to study how infants' sucking patterns respond to mechanical stimulation, providing insights into the sucking central pattern generator in human infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The actifier: a device for neurophysiological studies of orofacial control in human infants. Finan, DS., Barlow, SM.[2007]

A new device using digital pressure sensors in a pacifier can objectively measure non-nutritive sucking (NNS) in newborns, which is important for assessing their neural development and oral feeding skills.

Testing with nine newborns showed that this sensorized pacifier effectively captures sucking patterns, providing valuable data that could help monitor and improve the sucking abilities of premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensorized pacifier to evaluate non-nutritive sucking in newborns. Grassi, A., Cecchi, F., Sgherri, G., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06063122

Development of a Therapeutic Device to Improve Speech ... The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.

2. transformlabs.com transformlabs.com/case-studies/case-study-4-small-talk

smallTalk (formerly Thrive) ... speaker system to NICUs. Witness the positive impact on preterm infants' neurological development, with potential implications for the future of neonatal care.

3. trialx.com trialx.com/clinical-trials/listings/289249/development-of-a-therapeutic-device-to-improve-speech-sound-differentiation-in-preterm-infants/

Development of a Therapeutic Device to Improve Speech ... The study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier ...

4. smalltalk.tech smalltalk.tech/

smallTalk For Infants. For infants in the NICU, hearing their caregiver's voice helps in increasing cardiorespiratory stability and growth, improves deep sleep, and ...

5. reporter.nih.gov reporter.nih.gov/search/p8qO7TFSyUG3D1ufA6EYEw/project-details/11078358

Project Details - NIH RePORTER During this project we will complete development of the smallTalk NICU Active system and conduct a clinical trial to prove its efficacy in improving speech ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06063122?keyword=%22NICU%22

San Mateo Clinical Trial Development of a Therapeutic ... The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.