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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Healthy Volunteers: t
View:

• 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.

Locations
United States
South Carolina
Medical University of South Carolina Shawn Jenkins Children's Hospital
RECRUITING
Charleston
Contact Information
Primary
Haley Burdge
burdge@musc.edu
8432144089
Backup
Dorothea Jenkins
jenkd@musc.edu
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 10
Treatments
Experimental: taVNS treatment group
All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov