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

October 13, 2025 updated by: Medical University of South Carolina

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dorothea D. Jenkins, MD
  • Phone Number: 843-792-4341
  • Email: jenkd@musc.edu

Study Contact Backup

  • Name: Troy Huth, JD
  • Phone Number: 843-792-6752
  • Email: huth@musc.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bradycardia
Time Frame: 30 minutes during taVNS paired-feed for 10 days
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
Time Frame: 30 minutes during taVNS paired-feed up to 17 days
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
Time Frame: 17 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
white matter tract neuroplasticity
Time Frame: 10 days
change in fractional anisotropy by diffusion imaging before and after active vs sham treatment
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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