Smart pacifier aims to boost speech development in preterm infants

NCT ID NCT06063122

Recruiting now Symptom relief Sponsor: Thrive Neuromedical, LLC Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests a new pacifier device for preterm infants in the NICU. The device plays the mother's voice when the baby sucks, aiming to improve how babies tell different speech sounds apart. Researchers will measure brain activity with EEG in 203 infants to see if the device helps. If successful, it could support better language development in vulnerable newborns.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: smallTalk NICU Active device (a pacifier with a sensor that plays mother's voice when the infant sucks)
What this could lead to: If it works, this device could help preterm infants develop better speech and language skills, potentially reducing long-term developmental delays.
What could go wrong: This is an early-stage study with 203 participants, so results may not apply to all preterm infants. The device's effectiveness depends on individual factors like NICU noise levels, and it may not significantly improve outcomes.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PREMATURE BIRTH

Contacts and locations

Locations

Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Thrive Neuromedical, LLC
NOT_YET_RECRUITING

Chagrin Falls, Ohio, 44023, United States

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