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taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Medical University of South Carolina · NCT06417385

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8 mo+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
10
US sites recruiting
1
Study start
February 1, 2024
Record last updated
February 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities.

If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.

Being studied: taVNS soterix device

Conditions: Premature Birth; Breastfeeding, Exclusive; Feeding; Difficult, Newborn

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

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

    Charleston, SC 29425

    Site contact: Haley Burdge, MD · 8432144089 · burdge@musc.edu

Study contacts (from the official record)

  • Haley Burdge · 8432144089 · burdge@musc.edu
  • Dorothea Jenkins · jenkd@musc.edu
All breastfeeding studies in South Carolina →
taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge (NCT06417385) | Bored Studies