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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment smallTalk NICU Active, smallTalk NICU Active, Contingent Sucking Device for Speech Sound Differentiation?

Research shows that devices measuring non-nutritive sucking (NNS) in premature infants can predict their oral feeding abilities, suggesting that similar devices might help improve sucking skills. This indicates that using a contingent sucking device could potentially aid in speech sound differentiation by enhancing oral motor skills. ^{1 2 3 4 5}

How is the smallTalk NICU Active treatment different from other treatments for premature infants?

The smallTalk NICU Active treatment is unique because it uses a modified pacifier to stimulate and measure the sucking abilities of premature infants, helping to improve their oral feeding skills. This approach is non-invasive and focuses on enhancing the natural sucking reflex, which is crucial for feeding development in these infants. ^{1 6 7 8 9}

Research Team

Dean Koch

Principal Investigator

Thrive Neuromedical, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predicting Feeding Conditions of Premature Infants Through Non-Nutritive Sucking Skills Using a Sensitized Pacifier. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Assessing speech exposure in the NICU: Implications for speech enrichment for preterm infants. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Tools To Reduce Newborn Deaths In Africa. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Sensorized pacifier to evaluate non-nutritive sucking in newborns. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Auditory Brainstem Response in Preterm Infants in the Neonatal Intensive Care Unit. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The actifier: a device for neurophysiological studies of orofacial control in human infants. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

A computerized system to diagnose and treat neonatal apnea using vibrotactile stimulation. [2013]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Mechanically evoked perioral reflexes in premature and term human infants. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Foot vibrotactile device for central apnea interruption in premature infants. [2009]