BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding (BabyStrong I)

BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding

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.

Study Overview

• Status: Completed
• Conditions: Infant Feeding Problems, taVNS
• Intervention / Treatment: Device: transcutaneous auricular vagus nerve stimulation; Device: Sham transcutaneous auricular vagus nerve stimulation

Detailed Description

In this Phase I study, we will conduct a small-scale safety and feasibility study of 2 different taVNS units and ear electrode positions to optimize the BabyStrong portable taVNS feeding system and test the study design of randomization for 10 days. We will test the BabyStrong feeding system using up to n=10 active and n=10 sham taVNS in infants with twice daily treatment for 10 days, with cross over to alternate treatment for another 7days if there is no progress with feeds (increase <4ml/kg/d). G-tube placement will be arranged if infant continues to make no progress. If the infant attains full oral feeds and gains weight, they may be discharged at any time during the treatment protocol. The treatment assignment will be blinded to care providers, study personnel and parents. We will compare the number of participants who attain full oral feeds (= or > 130ml/kg/d with weight gain). Safety measures will be bradycardia and discomfort.

Criteria for success of BabyStrong feeding system: No sustained increase in discomfort scores; No bradycardia; attainment of full oral feeds in 50% of infants.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 5 months (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active taVNS cymba to tragus; We will deliver taVNS with the ear electrode positioned on left cymba and tragus, with pulses paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) < perceptual threshold (PT), 500microseconds, 25 Hertz (Hz).The ear electrode will be positioned on left tragus for active taVNS.	Device: transcutaneous auricular vagus nerve stimulation; Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.; Other Names: active taVNS
Sham Comparator: sham taVNS cymba to tragus; The ear electrode positioned on left cymba and tragus and as for active taVNS. We will test the PT with active stimulation, and then program a sham setting on the BabyStrong unit to deliver no current after the PT is determined.	Device: Sham transcutaneous auricular vagus nerve stimulation; Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding; Other Names: sham taVNS
Active Comparator: active taVNS cymba to mastoid; We will deliver taVNS with the ear electrode positioned on left cymba and mastoid, with pulses paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) < perceptual threshold (PT), 500microseconds, 25 Hertz (Hz).The ear electrode will be positioned on left tragus for active taVNS.	Device: transcutaneous auricular vagus nerve stimulation; Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.; Other Names: active taVNS
Sham Comparator: sham taVNS cymba to mastoid; The ear electrode positioned on left cymba and mastoid as for active taVNS. We will test the PT with active stimulation, and then program a sham setting on the BabyStrong unit to deliver no current after the PT is determined.	Device: Sham transcutaneous auricular vagus nerve stimulation; Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding; Other Names: sham taVNS
Experimental: active taVNS cross over to sham; infants who received 10 days of active taVNS but had <4ml/kg/d of oral feeding increase and crossed over the alternative treatment of sham taVNS	Device: transcutaneous auricular vagus nerve stimulation; Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.; Other Names: active taVNS; Device: Sham transcutaneous auricular vagus nerve stimulation; Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding; Other Names: sham taVNS
Experimental: sham taVNS cross over to active taVNS; infants who received 10 days of sham taVNS and had <4ml/kg/d of oral feeding increase and crossed over the alternative treatment of active taVNS	Device: transcutaneous auricular vagus nerve stimulation; Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.; Other Names: active taVNS; Device: Sham transcutaneous auricular vagus nerve stimulation; Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding; Other Names: sham taVNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bradycardia	safety : number of participants with episode of Heart rate < 80beats per minute for 5 seconds, according to the first assigned treatment	30 minutes during taVNS paired-feed for 10 days
Discomfort Scores	mean number of participants with Neonatal and Infant Pain scale (NIPS) >3 point increase, indicating worse discomfort according to the first assigned treatment	30 minutes during taVNS paired-feed up to 17 days
Participants Who Attain Full Oral Feeds	taVNS in participants who received tragus stimulation and attained full oral feeds (oral intake = or >130ml/kg/day with weight gain) according to the first assigned treatment	17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
white matter tract neuroplasticity	change in fractional anisotropy by diffusion imaging before and after active vs sham treatment	10 days

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 108881; 1R41HD104409 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share our extensive database generated during the conduct of this study with other interested researchers on a collaborative basis, including developmental assessment and neuroimaging data associated with this study. Data will be de-identified consistent with Institutional Review Board (IRB) regulations and approval, as well as NIH data sharing policies.
• IPD Sharing Time Frame: after primary data analysis is complete, pending FDA review
• IPD Sharing Access Criteria: We will identify where the data will be available and how to access the data in any publications and presentations that we author or co-author about these data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No