Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired With Breastfeeding to Improve Feeding in Premature or Sick Term Infants

What this Trial Is About

Researchers are evaluating whether pairing transcutaneous auricular vagus nerve stimulation (taVNS) with breastfeeding can improve the breastfeeding skills of premature or sick term infants admitted to the neonatal intensive care unit (NICU). The study aims to enhance motor learning related to breastfeeding, potentially increasing successful breastfeeding rates at discharge and beyond. The trial is conducted by the Medical University of South Carolina and involves infants born at or after 35 weeks gestational age who are clinically stable but struggling with breastfeeding despite support. Infants enrolled in the study will receive daily taVNS treatments during breastfeeding sessions for up to 14 days. Before each session, researchers will adjust the electrical stimulation to a level that produces a slight tingle without discomfort. This stimulation will coincide with the infant’s latching and sucking during feeding. The intervention uses a custom FDA-cleared device delivering microcurrent stimulation paired with breastfeeding five times per week over two weeks. During the study, researchers will collect data on feeding performance including pre- and post-feed weights, feeding duration, and observations of latch, suck, and swallow techniques provided by parents and lactation consultants. Parental satisfaction and the mother-infant bond will be assessed through surveys at the start, after one and two weeks, and again three months after the study ends. The main outcomes measured focus on the infant's ability to transfer milk effectively, sustain breastfeeding, and develop motor skills related to feeding over two weeks.

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge