Infant Feeding Problems, taVNSBabyStrong INCT04849507

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

A study testing transcutaneous auricular vagus nerve stimulation in people with Infant Feeding Problems, taVNS, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 weeks to 5 months
Conditions the study is for: Infant Feeding Problems, taVNS
What is being tested?: transcutaneous auricular vagus nerve stimulation
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2022to 1 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 weeks to 5 months
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

cardiomyopathy
unstable bradycardia
significant respiratory support
infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C>5.6% or ketonuria.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Infant Feeding Problems, taVNS
Being tested: transcutaneous auricular vagus nerve stimulation, Sham transcutaneous auricular vagus nerve stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcutaneous auricular vagus nerve stimulationDevice
Also called active taVNS
Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
Sham transcutaneous auricular vagus nerve stimulationDevice
Also called sham taVNS
Sham stimulation of the left auricular branch of the vagus nerves paired with oral feeding

Study groups in NCT04849507
Study group	Role	What they receive
active taVNS cymba to tragus	Active comparator	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. Receives: Device: transcutaneous auricular vagus nerve stimulation
sham taVNS cymba to tragus	Sham comparator	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. Receives: Device: Sham transcutaneous auricular vagus nerve stimulation
active taVNS cymba to mastoid	Active comparator	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. Receives: Device: transcutaneous auricular vagus nerve stimulation
sham taVNS cymba to mastoid	Sham comparator	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. Receives: Device: Sham transcutaneous auricular vagus nerve stimulation
active taVNS cross over to sham	Experimental	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 Receives: Device: transcutaneous auricular vagus nerve stimulation; Device: Sham transcutaneous auricular vagus nerve stimulation
sham taVNS cross over to active taVNS	Experimental	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 Receives: Device: transcutaneous auricular vagus nerve stimulation; Device: Sham transcutaneous auricular vagus nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Bradycardia
safety : number of participants with episode of Heart rate < 80beats per minute for 5 seconds, according to the first assigned treatment
Measured: 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
Measured: 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
Measured: 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20221 Aug 2024

First posted19 Apr 2021
Study start1 Aug 2022
Primary completion24 May 2024
Study completion1 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infant Feeding Problems, taVNSStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: If progress in daily oral feeding volumes is \<4ml/kg/d after 10 days with either treatment A or B, we will offer cross-over to the alternate treatment, remaining blinded to treatment assignment.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04849507
Sponsor's protocol ID: 108881
Other IDs: 1R41HD104409
Acronym: BabyStrong I
Status last verified: Oct 2025
First submitted: 13 Apr 2021
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding
ClinicalTrials.gov ID: NCT04849507
Acronym / sponsor ID: BabyStrong I / 108881
Conditions: Infant Feeding Problems, taVNS
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Aug 2022 (actual)
Primary completion: 24 May 2024 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 19 Apr 2021 (actual)
Results: Posted 28 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6
Model description: If progress in daily oral feeding volumes is <4ml/kg/d after 10 days with either treatment A or B, we will offer cross-over to the alternate treatment, remaining blinded to treatment assignment.

Arm	Type	Receives
active taVNS cymba to tragus	Active comparator	Device: transcutaneous auricular vagus nerve stimulationWe 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.
sham taVNS cymba to tragus	Sham comparator	Device: Sham transcutaneous auricular vagus nerve stimulationThe 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.
active taVNS cymba to mastoid	Active comparator	Device: transcutaneous auricular vagus nerve stimulationWe 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.
sham taVNS cymba to mastoid	Sham comparator	Device: Sham transcutaneous auricular vagus nerve stimulationThe 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.
active taVNS cross over to sham	Experimental	Device: transcutaneous auricular vagus nerve stimulation, Device: Sham transcutaneous auricular vagus nerve stimulationinfants 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
sham taVNS cross over to active taVNS	Experimental	Device: transcutaneous auricular vagus nerve stimulation, Device: Sham transcutaneous auricular vagus nerve stimulationinfants 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

Who may qualify

Ages: 2 weeks to 5 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

cardiomyopathy
unstable bradycardia
significant respiratory support
infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C>5.6% or ketonuria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
transcutaneous auricular vagus nerve stimulationAlso: active taVNSStimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Device	active taVNS cross over to sham, active taVNS cymba to mastoid, active taVNS cymba to tragus, sham taVNS cross over to active taVNS
Sham transcutaneous auricular vagus nerve stimulationAlso: sham taVNSSham stimulation of the left auricular branch of the vagus nerves paired with oral feeding	Device	active taVNS cross over to sham, sham taVNS cross over to active taVNS, sham taVNS cymba to mastoid, sham taVNS cymba to tragus

Primary outcome

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
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
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

Results and safety

Results posted to the registry on 28 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
active taVNS unit tragus/ cymba conchae	5	5
sham taVNS unit tragus/cymbae conchae	3	3
Active taVNS unit cymba conchae/mastoid	2	2
Sham taVNS unit cymbae conchae/mastoid	2	2
Active taVNs crossover to sham taVNS	2	2
Sham taVNS cross over to active taVNS	2	2

Primary outcome: Bradycardia

Time frame: 30 minutes during taVNS paired-feed for 10 days. Count of participants. Unit: Participants

Measure	active taVNS unit tragus/ cymba conchae n = 5	sham taVNS unit tragus/cymbae conchae n = 3	Active taVNS unit cymba conchae/mastoid n = 2	Sham taVNS unit cymbae conchae/mastoid n = 2	active taVNS cross over to sham taVNS n = 2	Sham taVNS cross over to active taVNS n = 2
Value	0	0	0	0	0	0

Population analysed: Crossover arms are exploratory due to the small sample size.

Primary outcome: Discomfort Scores

Time frame: 30 minutes during taVNS paired-feed up to 17 days. Count of participants. Unit: Participants

Measure	active taVNS unit tragus/ cymba conchae n = 5	sham taVNS unit tragus/cymbae conchae n = 3	Active taVNS unit cymba conchae/mastoid n = 2	Sham taVNS unit cymbae conchae/mastoid n = 2	active taVNS cross over to sham taVNS n = 2	sham taVNS cross over to active taVNS n = 2
Value	1	3	1	0	0	0

Population analysed: Crossover arms are exploratory due to the small sample size.

Primary outcome: Participants Who Attain Full Oral Feeds

Time frame: 17 days. Count of participants. Unit: Participants

Measure	active taVNS unit tragus/ cymba conchae n = 5	sham taVNS unit tragus/cymbae conchae n = 3	Active taVNS cymba conchae to mastoid n = 2	Sham taVNS cymba conchae to mastoid n = 2	active taVNS cross over to sham taVNS n = 2	sham taVNS cross over to active taVNS n = 2
Value	4	2	0	2	0	0

Population analysed: Crossover arms are exploratory due to the small sample size.

Adverse events

Time frame: collected over the acute treatment phase of the study (2-3 weeks) until Gastrostomy tube placement or discharge. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
active taVNS unit tragus/ cymba conchae	0 of 5 (0%)	0 of 5 (0%)	0 of 5
sham taVNS unit tragus/ cymba conchae	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Active taVNS unit cymba conchae/mastoid	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Sham taVNS unit cymba conchae/mastoid	0 of 2 (0%)	0 of 2 (0%)	0 of 2
active taVNS crossover to sham taVNS	0 of 2 (0%)	0 of 2 (0%)	0 of 2
sham taVNS cross over to active taVNS	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): small phase I study not powered for statistical analysis; Expected adverse events are reported as safety outcomes (Bradycardia, discomfort increase). There were no unanticipated AEs. Limitations: initial treatment assignment may have an effect that cannot be washed-out by cross-over to the other treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous auricular vagus nerve stimulation in people with Infant Feeding Problems, taVNS, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bradycardia (time frame: 30 minutes during taVNS paired-feed for 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.