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Can Skin-to-Skin and Mom's voice boost preemie brain power?

NCT ID NCT03232931

Knowledge-focused Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a combination of therapist skin-to-skin care and a device that plays the mother's voice when the baby sucks on a pacifier could improve brain development in preterm infants. 248 babies born between 32 and 36 weeks gestation were enrolled. The goal was to see if this multisensory intervention could lead to better language and motor skills later in childhood.

What this could mean

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

Active substance
Therapist skin-to-skin care and contingent parent's voice exposure (Pacifier Activated Lullaby)
What this could lead to
If successful, this could point toward a simple, parent-led therapy to support brain development in premature babies.
What could go wrong
This is a completed study, but results may not apply to all preterm infants. The intervention requires parent involvement, which may not be possible for all families.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

248 people

The number who actually took part.

Started

Oct 2018

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

32 to 36 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Hospitalization at a study location * Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation Exclusion Criteria: * Ventilation using an endotracheal tube * Major congenital malformations * Family history of genetic hearing loss * Use of sedatives or seizure medications Secondary Study Inclusion Criteria: * Enrolled in the control group of the main study

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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.

Preterm infant

Contacts and locations

Locations

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

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Other studies related to the condition(s) this trial covers.