Recruiting

taVNS

Sponsor:

Medical University of South Carolina

Code:

NCT06417385

Conditions

Premature Birth

Breastfeeding, Exclusive

Feeding; Difficult, Newborn

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

taVNS soterix device

Study Details

Brief summary:

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.

Conditions

Premature Birth

Breastfeeding, Exclusive

Feeding; Difficult, Newborn

Study ID

NCT06417385

Start date

Feb 1, 2024

Status verified date

Feb, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: taVNS treatment group

All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.

Interventions

taVNS soterix device

Soterix is a custom modified, FDA-cleared electrical stimulator that meets the criteria of the FDA for investigational use. Neoleads will be placed in order to deliver electrical stimulation using microcurrent (<2.5mA) with breastfeeding, on with sucking and swallowing and off with rest for 5 feeds per week for 2 weeks.

Primary outcome measure

  • Adequate volume transfer during breastfeeding [ Time Frame: 2 weeks ]
  • Infant's ability to sustain breastfeeding for a length of time [ Time Frame: 2 weeks ]
  • Targeted motor learning of skills involved in breastfeeding [ Time Frame: 2 weeks ]
  • Targeted motor learning of skills involved in breastfeeding [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Dorothea Jenkins

jenkd@musc.edu

Locations

Medical University of South Carolina Shawn Jenkins Children's Hospital

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Dorothea Jenkins, MD

jenkd@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-02-06.