An interventional study of taVNS soterix device in Premature Birth, Breastfeeding, Exclusive and Feeding; Difficult, Newborn, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 35 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 10 is below the median of 84 across 1,691 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.
Device: 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.
Adequate volume transfer during breastfeeding
Measured by pre- and post-feed weights (grams)
Time frame: 2 weeks
Infant's ability to sustain breastfeeding for a length of time
Average length of active feeding at the breast (minutes)
Time frame: 2 weeks
Targeted motor learning of skills involved in breastfeeding
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.
Time frame: 2 weeks
Targeted motor learning of skills involved in breastfeeding
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)
Time frame: 2 weeks
Frequency of breastfeeding assessed by study specific survey
Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey
Time frame: 2 months
Parent satisfaction with infant's ability to breastfeed assessed by study specific survey
Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey
Time frame: 2 months
Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey
Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey
Time frame: 2 months
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Medical University of South Carolina