BabyStrong II taVNS to help infants with feeding delays learn to feed
Official title: BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding
Run by Medical University of South Carolina · NCT07049952 · Data updated 2026-11-12
This study tests whether twice-daily, gentle electrical stimulation of the vagus nerve at the ear (taVNS), with an added antioxidant (N‑acetylcysteine) for infants of diabetic mothers when appropriate, helps newborns and term infants with feeding delays reach full oral feeds faster than sham stimulation.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 39 Weeks to 54 Weeks |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | November 16, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07049952 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are near-term or term infants (meeting the protocol's postmenstrual age and duration-of-feeding criteria) who are making minimal progress with oral feeds and are allowed to attempt PO feeding without therapist-imposed volume limits.
✕Probably not a fit
Infants with unstable apnea or bradycardia, significant respiratory support (CPAP/Vapotherm), cardiomyopathy, unrepaired major congenital anomalies that affect safe oral feeding, or congenital syndromes unlikely to feed are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled, triple-blinded trial testing the BabyStrong taVNS feeding system in infants with feeding delays, with sites led by the Medical University of South Carolina. Infants are stratified by infant-of-diabetic-mother (IDM) status and randomized to active taVNS (with or without N‑acetylcysteine for IDMs) or sham stimulation, with blinded treatment for 14 days followed by an optional open-label phase of up to 10 days. The main outcomes are the number of infants reaching full oral feeds, daily oral feeding volumes, and time to full feeds. The trial builds on pilot results and aims to generate safety and efficacy data to support an FDA submission and commercial development.
Why it matters
Potential benefit: If successful, the device could help more infants reach full oral feeds sooner, reduce the need for gastrostomy tubes or prolonged nasogastric feeding, and allow earlier discharge home.
How similar studies have gone: Early pilot work showed promising results, with 54% (19/35) of infants reaching full oral feeds within two weeks, but the approach remains relatively novel and has not yet been tested in a large randomized trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Shawn Jenkins Children's Hospital, Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Dorothea D JENKINS, MD — Medical University of South Carolina
- Study coordinator: Dorothea D Jenkins, MD
- Email: jenkd@musc.edu
- Phone: 843-792-2112
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.