Using a device to stimulate the vagus nerve to help infants feed better
BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding
This study is testing a new device that stimulates a nerve in the ear to see if it can help infants who have trouble feeding better and avoid needing a feeding tube.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Weeks to 5 Months |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04849507 on ClinicalTrials.gov |
What this trial studies
This Phase I study investigates the BabyStrong feeding system, which delivers transcutaneous auricular vagus nerve stimulation (taVNS) to improve oral feeding in infants who are struggling to feed adequately. The study will involve infants receiving either active or sham stimulation paired with bottle feeding over a 10-day period, with a crossover design if no progress is made. The primary outcomes will include changes in daily feeding volumes and diffusion MRI assessments of brain structure. The study aims to determine the safety and efficacy of this novel approach in preventing the need for G-tube placement in infants.
Who should consider this trial
Good fit: Ideal candidates are infants of any gestational age who have been unable to feed orally after a specified period and are likely to need a G-tube.
Not a fit: Patients with cardiomyopathy, unstable bradycardia, or significant respiratory support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve feeding outcomes for infants at risk of requiring G-tube placement.
How similar studies have performed: Previous studies using vagus nerve stimulation in similar contexts have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm * safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and * clinical team has determined will likely need a G-tube. Exclusion Criteria: * cardiomyopathy * unstable bradycardia * significant respiratory support * infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C\>5.6% or ketonuria.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Dorothea D. Jenkins, MD
- Email: jenkd@musc.edu
- Phone: 843-792-4341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.