BabyStrong II: gentle ear stimulation during bottle feeds to help babies learn to eat by mouth

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

NIH-funded research Frd Accel, LLC · NIH-11178706

This tests whether gentle ear (tragus) vagus-nerve stimulation given during bottle feeds helps preterm and brain-injured infants reach full oral feeding sooner.

Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionFrd Accel, LLC NIH-funded
Lab location1 site (Charleston, United States)
Project IDNIH-11178706 on NIH RePORTER

What this research studies

This project pairs a non-invasive ear (tragus) vagus nerve stimulation device with regular bottle feeding in the neonatal unit. Babies are randomly assigned to receive the stimulation during feeds or to continue usual feeding care while teams track feeding progress and time to full oral feeds. The approach is non-invasive and was piloted in infants, where over half of babies discussed for G-tube placement reached full feeds within two weeks. The team aims to turn this method into a therapy that helps infants go home sooner and avoid gastrostomy tubes.

Who could benefit from this research

Good fit: Preterm or term infants with brain injury who are hospitalized for feeding delays and are not yet reliably taking full oral feeds.

Not a fit: Infants who are already feeding well, are medically unstable, or have contraindications to vagus nerve stimulation may not benefit or be eligible.

Why it matters

Potential benefit: If successful, this could help more infants reach full oral feeding faster and reduce the need for G-tube placement.

How similar studies have performed: Early open-label pilot work in infants showed promising results—54% of babies discussed for G-tube placement reached full feeds within two weeks—so randomized testing is now under way.

Where this research is happening

Charleston, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Acquired brain injury
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.