# BabyStrong taVNS-Paired BottleFeeding to Improve Oral Feeding

> **NIH NIH R41** · FRD ACCEL, LLC · 2021 · $318,713

## Abstract

Project Summary
The long-term goal of this project proposal is to develop and commercialize a therapy to assist
pre-term, and term infants with hypoxic ischemic brain injury (HIE), with feeding difficulty.
Independent feeding is critical for infants to be discharged home with their families and avoid a
gastrostomy tube (G-tube) placement. The current standard of care for infants with feeding
difficulty involves early oromotor stimulation and feeding with therapists once daily for safe
feeding. Technologies on the market possess diagnostic capabilities that allow clinicians to
monitor feeding parameters, but no technologies actively improve oral feeding for discharge.
Our team previously initiated a first-in-infants pilot study in which we paired transcutaneous
auricular vagus nerve stimulation (taVNS) stimulation with bottle feeding to enhance motor
learning of feeding in preterm or term HIE infants, who were failing oral feeds. taVNS is a non-
invasive form of vagus nerve stimulation, which facilitates activity-dependent neuroplasticity.
During this pilot trial, our team developed custom open and closed-loop taVNS-paired feeding
systems to test initial efficacy. Preliminary data shows no significant adverse effects in the 27
patients treated with this novel therapy. Also 50% of infants achieved full oral feeds in 2 weeks
when they would have received a G-tube. For further clinical trial testing and commercialization,
we need to create a less expensive and compact set-up that is easier to use.
In this Phase I application, we propose the development of our BabyStrong taVNS bottle
feeding system, with subsequent validation in a small-scale safety and efficacy study. The
findings from this proposal will support our hypothesis that taVNS paired feedings will improve
daily feeding volumes for this vulnerable population and position us for a phase II randomized
controlled trial.

## Key facts

- **NIH application ID:** 10258359
- **Project number:** 1R41HD104409-01A1
- **Recipient organization:** FRD ACCEL, LLC
- **Principal Investigator:** DOROTHEA DENISE JENKINS
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $318,713
- **Award type:** 1
- **Project period:** 2021-06-07 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258359

## Citation

> US National Institutes of Health, RePORTER application 10258359, BabyStrong taVNS-Paired BottleFeeding to Improve Oral Feeding (1R41HD104409-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10258359. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*