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Zap to latch: nerve stimulation may help preemies breastfeed

NCT ID NCT06417385

Symptom relief Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests whether a gentle electrical stimulation of the vagus nerve (taVNS) during breastfeeding can help premature or sick infants learn to breastfeed better. Ten infants in the NICU will receive taVNS paired with breastfeeding for up to 14 days. Researchers will measure milk transfer, feeding duration, and latch quality to see if this approach improves breastfeeding skills before discharge.

What this could mean

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

Active substance
transcutaneous auricular vagus nerve stimulation (taVNS) device
What this could lead to
If it works, this could help premature or sick infants breastfeed more effectively, leading to better nutrition and bonding.
What could go wrong
This is a very small early study with only 10 infants, so results may not apply to all babies. The stimulation may not improve breastfeeding skills as hoped.

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

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

35 weeks and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 ≥ 35 weeks post-menstrual age, * Clinically stable, without significant respiratory support, * Deemed safe to breastfeed by OT/SLP/lactation, * Maternal interest in breastfeeding, * Are not breastfeeding well despite the assistance of a lactation consultant. Exclusion Criteria: * Cardiomyopathy, * Unstable bradycardia, * Significant respiratory support, * Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia, * Maternal HIV without adequate viral suppression, * Maternal illicit drug use.

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Conditions

The condition(s) this trial relates to.

Breast Feeding Premature Birth

As listed by the trial registrant

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

Breastfeeding, exclusive Feeding; difficult, newborn Premature birth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical University of South Carolina Shawn Jenkins Children's Hospital

    RECRUITING

    Charleston, South Carolina, 29425, United States

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