N/A
N=16
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Infant Feeding Problems, taVNS
Bottom Line
View on ClinicalTrials.gov: NCT04849507 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Bradycardia — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcutaneous auricular vagus nerve stimulation (Device); Sham transcutaneous auricular vagus nerve stimulation (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bradycardia |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Discomfort Scores |
1; 3; 1; 0; 0; 0 | — |
| PRIMARY Participants Who Attain Full Oral Feeds |
4; 2; 0; 2; 0; 0 | — |
Summary
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front part of the ear, the BabyStrong feeding system, to delivered transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings daily for 10 days. In an earlier study at Medical University of South Carolina (MUSC), this type of vagus nerve stimulation resulted in more than half of infants who were slated to receive G-tubes, taking full oral feeds by mouth and avoiding a G-tube. In this study some babies will receive the therapy for 10 days and others will get no stimulation. If no progress is made in feeding volumes by day 10, the infants will be switched to the other treatment for 7 days. Parents, study personnel, and care providers will be blinded to taVNS assignment. The electronic stimulation device is Federal Drug Administration (FDA)-cleared for investigational use, and the BabyStrong has been designated a Breakthrough Medical Device by the FDA. This study will be conducted in MUSC's Neonatal Intensive Care Unit.
Eligibility 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 is considering the need for 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.
Data sourced from ClinicalTrials.gov (NCT04849507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.