Actively Recruiting

Phase Not Applicable
Age: 35Weeks +
All Genders
Healthy Volunteers
NCT06417385

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Led by Medical University of South Carolina · Updated on 2026-02-06

10

Participants Needed

1

Research Sites

173 weeks

Total Duration

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AI-Summary

What this Trial 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.

CONDITIONS

Official Title

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Who Can Participate

Age: 35Weeks +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants at or beyond 35 weeks post-menstrual age
  • Clinically stable without significant respiratory support
  • Deemed safe to breastfeed by occupational therapist, speech-language pathologist, or lactation consultant
  • Maternal interest in breastfeeding
  • Infants not breastfeeding well despite lactation consultant assistance
Not Eligible

You will not qualify if you...

  • Cardiomyopathy
  • Unstable bradycardia
  • Significant respiratory support
  • No maternal interest in breastfeeding
  • Infant or mother with contraindications to breastfeeding such as infantile galactosemia
  • Maternal HIV without adequate viral suppression
  • Maternal illicit drug use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

H

Haley Burdge

CONTACT

D

Dorothea Jenkins

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge | DecenTrialz