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Mom's voice may boost preemie brain waves

NCT ID NCT05391633

Knowledge-focused Sponsor: University of New Mexico Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether playing a recording of a mother's voice to premature babies in the NICU could improve brain development, measured by EEG. Fourteen infants born between 28 and 32 weeks gestation were randomly assigned to hear either their mother's voice or a blank recording for 14 days. The study was terminated early, so results are limited.

What this could mean

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

Active substance
Recorded maternal voice
What this could lead to
If it works, this could point toward a simple, low-cost way to support brain development in premature babies.
What could go wrong
This was a very small, early study (14 infants) that was terminated, so results are limited and may not be reliable. The intervention is just a voice recording, so any effect is likely to be modest.

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

14 people

The number who actually took part.

Started

Feb 2022

Finished

Jun 2024

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

28 to 33 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: * Infants born at 28 0/7 - 32 3/7 weeks gestation (to allow for infants born at 32 3/7 weeks to have initial EEG performed after 72 hours of life and prior to initiating intervention or non-intervention arm at 33 0/7 weeks gestation) * Mother available to provide voice recording, and have ability to converse and read in English (as the scripted content for the intervention will be provided in English) Exclusion Criteria: * Infant with Critical Congenital Cardiac Disease * Infant with Chromosomal anomaly or Inborn Error of Metabolism * Infant with known Neurologic disorder/abnormality - including hypoxic-ischemic encephalopathy (HIE), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), seizure activity, anatomic abnormality * Infant receiving antiepileptic or sedation medications prior to EEG * Initial EEG abnormal with epileptiform activity or not consistent with corrected gestational age * Mother not available to provide voice recording in English * Unable to obtain consent from mother due to maternal health issues following delivery (such as mother requiring intubation or sedation following delivery * Mothers who are prisoners (as the study team would like to have continuing communication during the study period as needed) * Mothers who are \<18 years of age will not be approached for consent * Any mother that is not able to consent due to having a legal representative will not be approached for consent * Any infant that is planned to be placed for adoption, is in foster care or is a ward of the state

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Conditions

The condition(s) this trial relates to.

learning disability Premature Birth

As listed by the trial registrant

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

Development delay Premature birth Prematurity

Contacts and locations

Locations

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

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