This study is testing a new device called smallTalk NICU Active, designed to help preterm infants in the NICU (Neonatal Intensive Care Unit) better differentiate speech sounds. The device uses a special pacifier with a sensor that delivers a parent's voice when the baby sucks. This aims to improve how their brains process speech, which is important for language development. Preterm infants often have difficulty with speech sound processing, which can lead to language delays. This study is looking for 203 preterm infants, aged 32 to 35 weeks gestational age (the age of the baby from conception), who were born at 35 weeks gestational age or earlier. To see if the device works, researchers will measure brain activity related to sensory processing using an ERP (Event-Related Potential) recording before and after the intervention. The study's current status is unclear.

Study design

This is an interventional study planning to enroll 203 participants. The study is testing a device called smallTalk NICU Active.

What's involved

Participants will have an ERP recording two days before starting the intervention. The intervention involves 20 sessions over three weeks, and another ERP recording will be done within 24 hours of the last session.

Compensation

Not stated in the trial record.

Follow-up

Participants are followed for the duration of the intervention (three weeks) and for 24 hours after the last session for the final ERP test.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.