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NCT Number: NCT06417385

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

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.

Recruiting

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Key information

Age range

35 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Dorothea Jenkins, MD

CONTACT

[email protected]

Haley Burdge, MD

CONTACT

[email protected]

8432144089

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

taVNS soterix device

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 outcomes

  1. Adequate volume transfer during breastfeeding

    Time frame: 2 weeks

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

  2. Infant's ability to sustain breastfeeding for a length of time

    Time frame: 2 weeks

    Average length of active feeding at the breast (minutes)

  3. Targeted motor learning of skills involved in breastfeeding

    Time frame: 2 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.

  4. Targeted motor learning of skills involved in breastfeeding

    Time frame: 2 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)

Secondary outcomes

  1. Frequency of breastfeeding assessed by study specific survey

    Time frame: 2 months

    Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey

  2. Parent satisfaction with infant's ability to breastfeed assessed by study specific survey

    Time frame: 2 months

    Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey

  3. Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey

    Time frame: 2 months

    Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey

Study contacts

Contact information is provided by the study sponsor or research team.

Dorothea Jenkins

CONTACT

[email protected]

Haley Burdge

CONTACT

[email protected]

8432144089

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 16, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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