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taVNS-Paired Breastfeeding for Premature and Sick Infants

This study is exploring if a device called taVNS (transcutaneous vagus nerve stimulation) can help premature or sick infants learn to breastfeed better. Researchers will recruit 10 infants who are at least 35 weeks old and are having trouble breastfeeding, even with help from a lactation consultant. The taVNS soterix device delivers a very mild electrical stimulation, which will be paired with breastfeeding sessions once a day for up to 14 days. The goal is to see if this stimulation helps infants improve their ability to transfer enough milk and sustain breastfeeding for a longer time, with measurements taken at 2 weeks.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is not specified if the study is randomized or blinded.
What's involved
Your infant would receive taVNS treatments once a day paired with breastfeeding for up to 14 days. Before each treatment, a researcher will determine the appropriate level of electrical stimulation.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as adequate milk transfer and sustained breastfeeding, will be measured at 2 weeks.

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NCT06417385

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Recruiting
NAAges 35+InterventionalTreatment
Medical University of South Carolina
~10 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:taVNS soterix device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adequate volume transfer during breastfeeding
Measured over 2 weeks
+3 more outcomes measured

Conditions

Premature Birth
Breastfeeding, Exclusive
Feeding; Difficult, Newborn

Explore related trials

Feeding ProblemPreterm Birth

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Haley Burdge · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Haley Burdge
[email protected]
8432144089
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Adequate volume transfer during breastfeeding2 weeks

    Measured by pre- and post-feed weights (grams)

  • Infant's ability to sustain breastfeeding for a length of time2 weeks

    Average length of active feeding at the breast (minutes)

  • Targeted motor learning of skills involved in breastfeeding2 weeks

    Demonstration of successful latch, suck, and swallow techniques by the infant per LATCH scoring (L= latch, A= audible swallowing, T= type of nipple (inverted, flat, everted after stimulation), C= Comfort of mother during feed, H= Hold/positioning of infant), scoring 0-10 (2 points per question) with 10 being the highest and optimal score.

  • Targeted motor learning of skills involved in breastfeeding2 weeks

    Demonstration of successful latch, suck, and swallow techniques by the infant by study personnel descriptions (Only lactation consultants are trained to obtain LATCH scores, thus when no lactation consultant is present, study personnel will simply describe infant's demonstrated skills during the session without a specific measurement tool)