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BabySTrong II taVNS Feeding Trial

BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding

Who can join

39 Weeks – 54 Weeks · All sexes

Inclusion Criteria:

* infants \>39 weeks PMA making minimal progress in oral feeds
* trying to learn feeding for at least 2wks if beginning feeds at term (\>37wks PMA), and 4wks if beginning feeds \<36wks PMA,
* may po every feed without volume limitations by therapists

Exclusion Criteria:

* cardiomyopathy
* unstable apnea/bradycardia
* significant respiratory support (CPAP/ Vapotherm)
* unrepaired major congenital anomalies that affect safe po feeding or impose volume restrictions
* congenital syndromes unlikely to orally feed

About the study

The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the burdens of of a gastrostomy tube (G-tube) or prolonged home nasogastric feeding. Few other therapies exist for infants who are not making progress with feeding volumes at term age.

To tackle this problem, we took the novel approach of pairing non-invasive nerve stimulation of the vagus nerve at the ear (taVNS) stimulation with the motor skills of feeding. In our pilot studies, 54% (19 out of 35) infants with feeding delays whose families were in discussions for G-tube placement, reached full oral feeds within 2 weeks, and infants who did not reach full feeds still improved their daily oral feeding volumes. Infants who got to full feeds showed stronger and more complex brain circuits associated with feeding motor skills.

With this trial we will test the BabySTrong taVNS feeding system in a multicenter, randomized, controlled, blinded trial to show how well this feeding system works in improving the daily feeding volumes, the days to full oral feeds, and/or the number of infants who avoid G-tube/ home NG placement, and increasing connections in brain circuits. If this groundbreaking new approach to infant feeding is successful, we may decrease how long infants are in the hospital, costs with Gtubes and home NG feeds, and family and care provider burdens. The findings from this proposal will be used in our FDA application for the BabySTrong feeding system.

What is being tested

• taVNS (device)
• NAC and taVNS (combination product)
• inactive taVNS (device)
• sterile water and inactive taVNS (combination product)

Sponsor: Medical University of South Carolina · Participants: 88 · Started: Nov 16, 2025

Contact the study team

• Dorothea D Jenkins, MD · Phone: 843-792-2112
• Gary Connor, RN · Phone: 207-281-2652

Official record on ClinicalTrials.gov — NCT07049952

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.