Feeding DelaysPhase 2/3BabySTrong IINCT07049952
BabySTrong II taVNS Feeding Trial
A Phase 2/3 study testing taVNS, NAC and taVNS and inactive taVNS in people with Feeding Delays and Neonates and Term Infants, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the burdens of of a gastrostomy tube (G-tube) or prolonged home nasogastric feeding. Read more about this study
- Who is it for?
- Ages 39 to 54 weeks
- Conditions the study is for
- Feeding Delays, Neonates and Term Infants
- What is being tested?
- taVNS, NAC and taVNS and inactive taVNS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2025to 30 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 39 to 54 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants >39 weeks PMA making minimal progress in oral feeds
- trying to learn feeding for at least 2wks if beginning feeds at term (>37wks PMA), and 4wks if beginning feeds <36wks PMA,
- may po every feed without volume limitations by therapists
Who cannot join
- cardiomyopathy
- unstable apnea/bradycardia
- significant respiratory support (CPAP/ Vapotherm)
- unrepaired major congenital anomalies that affect safe po feeding or impose volume restrictions
- congenital syndromes unlikely to orally feed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shawn Jenkins Children's Hospital, Medical University of South Carolina
Charleston, South Carolina, 29425
Dorothea D Jenkins, MD, 843-792-2112, jenkd@musc.edu
Sandra Garner, PharmD
About this study
Official title: BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding
The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the burdens of of a gastrostomy tube (G-tube) or prolonged home nasogastric feeding. Few other therapies exist for infants who are not making progress with feeding volumes at term age.
To tackle this problem, we took the novel approach of pairing non-invasive nerve stimulation of the vagus nerve at the ear (taVNS) stimulation with the motor skills of feeding. In our pilot studies, 54% (19 out of 35) infants with feeding delays whose families were in discussions for G-tube placement, reached full oral feeds within 2 weeks, and infants who did not reach full feeds still improved their daily oral feeding volumes. Infants who got to full feeds showed stronger and more complex brain circuits associated with feeding motor skills.
With this trial we will test the BabySTrong taVNS feeding system in a multicenter, randomized, controlled, blinded trial to show how well this feeding system works in improving the daily feeding volumes, the days to full oral feeds, and/or the number of infants who avoid G-tube/ home NG placement, and increasing connections in brain circuits. If this groundbreaking new approach to infant feeding is successful, we may decrease how long infants are in the hospital, costs with Gtubes and home NG feeds, and family and care provider burdens. The findings from this proposal will be used in our FDA application for the BabySTrong feeding system.
Read the detailed description
In this STTR, we will test the safety and efficacy of the BabyStrong taVNS feeding system in infants with feeding delays in a randomized, controlled, triple blinded, multicenter trial. With this safety and efficacy data, we intend to apply for FDA approval and commercially develop the BabyStrong feeding device.
Aim 1) Determine if twice daily active taVNS-paired feeding treatment increases the number of infants reaching full oral feeds or daily oral feeding volumes, or decreases the time to attain full oral feeds compared with infants receiving sham stimulation in a randomized, controlled, triple-blinded trial. We will randomize based on non-IDM or IDM status to 4 groups: IDMs will be randomized 1:1 to Active taVNS-paired feeds (Group T), or sham taVNS paired with feeds (Non-IDM Control); For IDM infants we will randomize 1:1 to N-acetylcysteine (NAC) and active taVNS-paired feeds (Group NT), or placebo and sham taVNS (IDM Control). Blinded randomized treatments will continue for 14 days, then all infants may progress to open label treatment, based on IDM status, for another 10days or less if full oral feeds or a decision to place a G-tube is reached. This study design will allow us to randomize to appropriate treatment based on IDM status. We will combine groups for analyses (Any active taVNS versus Control groups (IDM and Non-IDM combined), while controlling for IDM status. We hypothesize that any taVNS treatment (T + NT) will be effective at improving oral feeds over control (C).
We will also perform within stratified group analyses of active treatment versus control. We will use the non-IDM group results to support an FDA application.
Aim 2) Determine if active taVNS-paired feeding induces neuroplasticity compared with sham treated infants. We will measure diffusion kurtosis and tensor metrics in DKI scans at baseline and at the end of the 14d randomized treatment. We expect increased complexity (mean kurtosis) in corticospinal tracts in active vs sham groups.
Aim 3) Use safety and efficacy data to finalize an application for FDA approval of the BabyStrong, as a system with demonstrated potential to accelerate oromotor learning and decrease the need for Gubes and home NG feeds in infants.
- Conditions
- Feeding Delays, Neonates and Term Infants
- Being tested
- taVNS, NAC and taVNS, inactive taVNS, sterile water and inactive taVNS
- Keywords
- taVNS, feeding delays, infants, IDM, non-IDM, G-tube, transcutaneous auricular vagus nerve stimulation, Home NG feeds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Active or inactive non-invasive vagus nerve stimulation of the auricular branch of the vagus nerve paired with 2 oral feedings/day for 14d
NAC and taVNSCombination product
NAC 100 mg/kg diluted 1:3 with sterile water (or equal volume sterile water), q6h NG 1h before a feed for 4d prior to delivering active or sham taVNS paired with 2 feeds/day for 14d with NAC (or sterile water).
inactive taVNSDevice
inactive transcutaneous auricular vagus nerve stimulation with 2 feeds/day x 14 days
sterile water and inactive taVNSCombination product
Sterile water per NG tube every 6h for 4 days, then continuing with 14days of inactive taVNS paired with oral feeding
| Study group | Role | What they receive |
|---|---|---|
| Non-IDM active taVNS | Active comparator | Non-IDM (Infants not product of diabetic mothers) will receive active taVNS with 2 feeds/day x 14 days Receives: Device: taVNS |
| Non-IDM Control | Sham comparator | Non-IDM (Infants not product of diabetic mothers) will receive inactive/sham taVNS paired with 2 oral feedings a day for 14 days. Receives: Device: inactive taVNS |
| IDM NAC and active taVNS | Active comparator | Infants of diabetic mothers will receive N-acetylcysteine by NG tube every 6h and active taVNS paired with 2 oral feedings a day, as a drug and device combination treatment for 14 days. Receives: Combination Product: NAC and taVNS |
| IDM Control | Sham comparator | Infants of diabetic mothers will receive sterile water and inactive taVNS paired with 2 oral feedings a day, as a placebo drug and sham device combination treatment, for 14 days. Receives: Combination Product: sterile water and inactive taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants at full oral feeds
number of participants achieving full oral feeds receiving ANY active taVNS (groups T+NT), vs Control (IDM combined with Non IDM control groups), based on the randomized assignment.
Measured: 24 days
rate of increase in daily oral feeding volumes
mean daily rate of increase in oral feeding volumes in any active taVNS group (T+NT) vs Control (IDM and Non-IDM combined), based on randomized treatment assignment.
Measured: 7days / 10days
Secondary outcomes (2)
time to full oral feeds
days to full oral feeds in any taVNS (groups T+NT) vs Control
Measured: 24 days
Neuroplasticity via DKI
increased mean kurtosis (complexity ) or FA (integrity) in corticospinal tracts in any active taVNS (Groups T+ NT) vs Control groups
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start16 Nov 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Feeding DelaysStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will stratify randomization based on non-IDM or IDM status (IDM is defined by obstetrical care providers, HgbA1C \> 5.6%, or ketonuria), and then by oral feeding volume intake of \<40ml/kg/d or \>= 40ml/kg/d. For non-IDM we will use a device treatment: we will randomize 1:1 to active taVNS (Group T), or sham taVNS (Group C control non-IDM) paired with feeding twice daily for 14 days. For IDM cohort we will use a drug and device combination: we will randomize 1:1 to NAC and active taVNS-paired feeds (Group NT) or sham taVNS and placebo (Group C control IDM) for 14d. After the 14d period, all groups will receive 10d of open-label treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dorothea Jenkins, Medical University of South Carolina
- Investigators
- Dorothea D JENKINS, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049952
- Sponsor's protocol ID
- WCG 20250610
- Other IDs
- R42HD104409
- Acronym
- BabySTrong II
- Status last verified
- Nov 2025
- First submitted
- 25 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will preserve and share the subject level feeding, heart rate, and developmental test data with unique identifiers. The individual MRI scans will be preserved in Dicom and .rda format; and the VFSS in video files with same unique, coded identifiers.
Publications
Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.
PubMed 29361441Badran BW, Mithoefer OJ, Summer CE, LaBate NT, Glusman CE, Badran AW, DeVries WH, Summers PM, Austelle CW, McTeague LM, Borckardt JJ, George MS. Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Brain Stimul. 2018 Jul-Aug;11(4):699-708. doi: 10.1016/j.brs.2018.04.004. Epub 2018 Apr 6.
PubMed 29716843Badran BW, Jenkins DD, DeVries WH, Dancy M, Summers PM, Mappin GM, Bernstein H, Bikson M, Coker-Bolt P, George MS. Transcutaneous auricular vagus nerve stimulation (taVNS) for improving oromotor function in newborns. Brain Stimul. 2018 Sep-Oct;11(5):1198-1200. doi: 10.1016/j.brs.2018.06.009. Epub 2018 Jun 30. No abstract available.
PubMed 30146041Moss HG, Brown TR, Wiest DB, Jenkins DD. N-Acetylcysteine rapidly replenishes central nervous system glutathione measured via magnetic resonance spectroscopy in human neonates with hypoxic-ischemic encephalopathy. J Cereb Blood Flow Metab. 2018 Jun;38(6):950-958. doi: 10.1177/0271678X18765828. Epub 2018 Mar 21.
PubMed 29561203Badran BW, Brown JC, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, DeVries WH, Austelle CW, McTeague LM, Yu A, Bikson M, Jenkins DD, George MS. Tragus or cymba conchae? Investigating the anatomical foundation of transcutaneous auricular vagus nerve stimulation (taVNS). Brain Stimul. 2018 Jul-Aug;11(4):947-948. doi: 10.1016/j.brs.2018.06.003. Epub 2018 Jun 6. No abstract available.
PubMed 29895444Badran BW, Yu AB, Adair D, Mappin G, DeVries WH, Jenkins DD, George MS, Bikson M. Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. J Vis Exp. 2019 Jan 7;(143):10.3791/58984. doi: 10.3791/58984.
PubMed 30663712Badran BW, Jenkins DD, Cook D, Thompson S, Dancy M, DeVries WH, Mappin G, Summers P, Bikson M, George MS. Transcutaneous Auricular Vagus Nerve Stimulation-Paired Rehabilitation for Oromotor Feeding Problems in Newborns: An Open-Label Pilot Study. Front Hum Neurosci. 2020 Mar 18;14:77. doi: 10.3389/fnhum.2020.00077. eCollection 2020.
PubMed 32256328Aljuhani T, Haskin H, Davis S, Reiner A, Moss HG, Badran BW, George MS, Jenkins D, Coker-Bolt P. Transcutaneous auricular vagus nerve stimulation (taVNS) given for poor feeding in at-risk infants also improves their motor abilities. J Pediatr Rehabil Med. 2022;15(3):447-457. doi: 10.3233/PRM-210090.
PubMed 36093716Jenkins DD, Moss HG, Adams LE, Hunt S, Dancy M, Huffman SM, Cook D, Jensen JH, Summers P, Thompson S, George MS, Badran BW. Higher Dose Noninvasive Transcutaneous Auricular Vagus Nerve Stimulation Increases Feeding Volumes and White Matter Microstructural Complexity in Open-Label Study of Infants Slated for Gastrostomy Tube. J Pediatr. 2023 Nov;262:113563. doi: 10.1016/j.jpeds.2023.113563. Epub 2023 Jun 16.
PubMed 37329979Aljuhani T, Coker-Bolt P, Katikaneni L, Ramakrishnan V, Brennan A, George MS, Badran BW, Jenkins D. Use of non-invasive transcutaneous auricular vagus nerve stimulation: neurodevelopmental and sensory follow-up. Front Hum Neurosci. 2023 Nov 9;17:1297325. doi: 10.3389/fnhum.2023.1297325. eCollection 2023.
PubMed 38021221Jenkins DD, Garner SS, Brennan A, Morris J, Bonham K, Adams L, Hunt S, Moss H, Badran BW, George MS, Wiest DB. Transcutaneous auricular vagus nerve stimulation may benefit from the addition of N-acetylcysteine to facilitate motor learning in infants of diabetic mothers failing oral feeds. Front Hum Neurosci. 2024 May 22;18:1373543. doi: 10.3389/fnhum.2024.1373543. eCollection 2024.
PubMed 38841121
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding
- ClinicalTrials.gov ID
- NCT07049952
- Acronym / sponsor ID
- BabySTrong II / WCG 20250610
- Conditions
- Feeding Delays, Neonates and Term Infants
- Keywords
- taVNS, feeding delays, infants, IDM, non-IDM, G-tube, transcutaneous auricular vagus nerve stimulation, Home NG feeds
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- 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
- 16 Nov 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the burdens of of a gastrostomy tube (G-tube) or prolonged home nasogastric feeding. Few other therapies exist for infants who are not making progress with feeding volumes at term age.
To tackle this problem, we took the novel approach of pairing non-invasive nerve stimulation of the vagus nerve at the ear (taVNS) stimulation with the motor skills of feeding. In our pilot studies, 54% (19 out of 35) infants with feeding delays whose families were in discussions for G-tube placement, reached full oral feeds within 2 weeks, and infants who did not reach full feeds still improved their daily oral feeding volumes. Infants who got to full feeds showed stronger and more complex brain circuits associated with feeding motor skills.
With this trial we will test the BabySTrong taVNS feeding system in a multicenter, randomized, controlled, blinded trial to show how well this feeding system works in improving the daily feeding volumes, the days to full oral feeds, and/or the number of infants who avoid G-tube/ home NG placement, and increasing connections in brain circuits. If this groundbreaking new approach to infant feeding is successful, we may decrease how long infants are in the hospital, costs with Gtubes and home NG feeds, and family and care provider burdens. The findings from this proposal will be used in our FDA application for the BabySTrong feeding system.
Detailed description
In this STTR, we will test the safety and efficacy of the BabyStrong taVNS feeding system in infants with feeding delays in a randomized, controlled, triple blinded, multicenter trial. With this safety and efficacy data, we intend to apply for FDA approval and commercially develop the BabyStrong feeding device.
Aim 1) Determine if twice daily active taVNS-paired feeding treatment increases the number of infants reaching full oral feeds or daily oral feeding volumes, or decreases the time to attain full oral feeds compared with infants receiving sham stimulation in a randomized, controlled, triple-blinded trial. We will randomize based on non-IDM or IDM status to 4 groups: IDMs will be randomized 1:1 to Active taVNS-paired feeds (Group T), or sham taVNS paired with feeds (Non-IDM Control); For IDM infants we will randomize 1:1 to N-acetylcysteine (NAC) and active taVNS-paired feeds (Group NT), or placebo and sham taVNS (IDM Control). Blinded randomized treatments will continue for 14 days, then all infants may progress to open label treatment, based on IDM status, for another 10days or less if full oral feeds or a decision to place a G-tube is reached. This study design will allow us to randomize to appropriate treatment based on IDM status. We will combine groups for analyses (Any active taVNS versus Control groups (IDM and Non-IDM combined), while controlling for IDM status. We hypothesize that any taVNS treatment (T + NT) will be effective at improving oral feeds over control (C).
We will also perform within stratified group analyses of active treatment versus control. We will use the non-IDM group results to support an FDA application.
Aim 2) Determine if active taVNS-paired feeding induces neuroplasticity compared with sham treated infants. We will measure diffusion kurtosis and tensor metrics in DKI scans at baseline and at the end of the 14d randomized treatment. We expect increased complexity (mean kurtosis) in corticospinal tracts in active vs sham groups.
Aim 3) Use safety and efficacy data to finalize an application for FDA approval of the BabyStrong, as a system with demonstrated potential to accelerate oromotor learning and decrease the need for Gubes and home NG feeds in infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- We will stratify randomization based on non-IDM or IDM status (IDM is defined by obstetrical care providers, HgbA1C > 5.6%, or ketonuria), and then by oral feeding volume intake of <40ml/kg/d or >= 40ml/kg/d. For non-IDM we will use a device treatment: we will randomize 1:1 to active taVNS (Group T), or sham taVNS (Group C control non-IDM) paired with feeding twice daily for 14 days. For IDM cohort we will use a drug and device combination: we will randomize 1:1 to NAC and active taVNS-paired feeds (Group NT) or sham taVNS and placebo (Group C control IDM) for 14d. After the 14d period, all groups will receive 10d of open-label treatment.
| Arm | Type | Receives |
|---|---|---|
| Non-IDM active taVNS | Active comparator | Device: taVNSNon-IDM (Infants not product of diabetic mothers) will receive active taVNS with 2 feeds/day x 14 days |
| Non-IDM Control | Sham comparator | Device: inactive taVNSNon-IDM (Infants not product of diabetic mothers) will receive inactive/sham taVNS paired with 2 oral feedings a day for 14 days. |
| IDM NAC and active taVNS | Active comparator | Combination Product: NAC and taVNSInfants of diabetic mothers will receive N-acetylcysteine by NG tube every 6h and active taVNS paired with 2 oral feedings a day, as a drug and device combination treatment for 14 days. |
| IDM Control | Sham comparator | Combination Product: sterile water and inactive taVNSInfants of diabetic mothers will receive sterile water and inactive taVNS paired with 2 oral feedings a day, as a placebo drug and sham device combination treatment, for 14 days. |
Who may qualify
- Ages
- 39 to 54 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infants >39 weeks PMA making minimal progress in oral feeds
- trying to learn feeding for at least 2wks if beginning feeds at term (>37wks PMA), and 4wks if beginning feeds <36wks PMA,
- may po every feed without volume limitations by therapists
Key exclusion criteria (5 listed)
- cardiomyopathy
- unstable apnea/bradycardia
- significant respiratory support (CPAP/ Vapotherm)
- unrepaired major congenital anomalies that affect safe po feeding or impose volume restrictions
- congenital syndromes unlikely to orally feed
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 |
|---|---|---|
| taVNSActive or inactive non-invasive vagus nerve stimulation of the auricular branch of the vagus nerve paired with 2 oral feedings/day for 14d | Device | Non-IDM active taVNS |
| NAC and taVNSNAC 100 mg/kg diluted 1:3 with sterile water (or equal volume sterile water), q6h NG 1h before a feed for 4d prior to delivering active or sham taVNS paired with 2 feeds/day for 14d with NAC (or sterile water). | Combination product | IDM NAC and active taVNS |
| inactive taVNSinactive transcutaneous auricular vagus nerve stimulation with 2 feeds/day x 14 days | Device | Non-IDM Control |
| sterile water and inactive taVNSSterile water per NG tube every 6h for 4 days, then continuing with 14days of inactive taVNS paired with oral feeding | Combination product | IDM Control |
Primary outcome
number of participants at full oral feeds
Time frame: 24 days
number of participants achieving full oral feeds receiving ANY active taVNS (groups T+NT), vs Control (IDM combined with Non IDM control groups), based on the randomized assignment.
rate of increase in daily oral feeding volumes
Time frame: 7days / 10days
mean daily rate of increase in oral feeding volumes in any active taVNS group (T+NT) vs Control (IDM and Non-IDM combined), based on randomized treatment assignment.
2 secondary outcomes
time to full oral feeds
Time frame: 24 days
Neuroplasticity via DKI
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 29361441Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.
- Background: PubMed 29716843Badran BW, Mithoefer OJ, Summer CE, LaBate NT, Glusman CE, Badran AW, DeVries WH, Summers PM, Austelle CW, McTeague LM, Borckardt JJ, George MS. Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Brain Stimul. 2018 Jul-Aug;11(4):699-708. doi: 10.1016/j.brs.2018.04.004. Epub 2018 Apr 6.
- Background: PubMed 30146041Badran BW, Jenkins DD, DeVries WH, Dancy M, Summers PM, Mappin GM, Bernstein H, Bikson M, Coker-Bolt P, George MS. Transcutaneous auricular vagus nerve stimulation (taVNS) for improving oromotor function in newborns. Brain Stimul. 2018 Sep-Oct;11(5):1198-1200. doi: 10.1016/j.brs.2018.06.009. Epub 2018 Jun 30. No abstract available.
- Background: PubMed 29561203Moss HG, Brown TR, Wiest DB, Jenkins DD. N-Acetylcysteine rapidly replenishes central nervous system glutathione measured via magnetic resonance spectroscopy in human neonates with hypoxic-ischemic encephalopathy. J Cereb Blood Flow Metab. 2018 Jun;38(6):950-958. doi: 10.1177/0271678X18765828. Epub 2018 Mar 21.
- Background: PubMed 29895444Badran BW, Brown JC, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, DeVries WH, Austelle CW, McTeague LM, Yu A, Bikson M, Jenkins DD, George MS. Tragus or cymba conchae? Investigating the anatomical foundation of transcutaneous auricular vagus nerve stimulation (taVNS). Brain Stimul. 2018 Jul-Aug;11(4):947-948. doi: 10.1016/j.brs.2018.06.003. Epub 2018 Jun 6. No abstract available.
- Background: PubMed 30663712Badran BW, Yu AB, Adair D, Mappin G, DeVries WH, Jenkins DD, George MS, Bikson M. Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. J Vis Exp. 2019 Jan 7;(143):10.3791/58984. doi: 10.3791/58984.
- Background: PubMed 32256328Badran BW, Jenkins DD, Cook D, Thompson S, Dancy M, DeVries WH, Mappin G, Summers P, Bikson M, George MS. Transcutaneous Auricular Vagus Nerve Stimulation-Paired Rehabilitation for Oromotor Feeding Problems in Newborns: An Open-Label Pilot Study. Front Hum Neurosci. 2020 Mar 18;14:77. doi: 10.3389/fnhum.2020.00077. eCollection 2020.
- Background: PubMed 36093716Aljuhani T, Haskin H, Davis S, Reiner A, Moss HG, Badran BW, George MS, Jenkins D, Coker-Bolt P. Transcutaneous auricular vagus nerve stimulation (taVNS) given for poor feeding in at-risk infants also improves their motor abilities. J Pediatr Rehabil Med. 2022;15(3):447-457. doi: 10.3233/PRM-210090.
- Background: PubMed 37329979Jenkins DD, Moss HG, Adams LE, Hunt S, Dancy M, Huffman SM, Cook D, Jensen JH, Summers P, Thompson S, George MS, Badran BW. Higher Dose Noninvasive Transcutaneous Auricular Vagus Nerve Stimulation Increases Feeding Volumes and White Matter Microstructural Complexity in Open-Label Study of Infants Slated for Gastrostomy Tube. J Pediatr. 2023 Nov;262:113563. doi: 10.1016/j.jpeds.2023.113563. Epub 2023 Jun 16.
- Background: PubMed 38021221Aljuhani T, Coker-Bolt P, Katikaneni L, Ramakrishnan V, Brennan A, George MS, Badran BW, Jenkins D. Use of non-invasive transcutaneous auricular vagus nerve stimulation: neurodevelopmental and sensory follow-up. Front Hum Neurosci. 2023 Nov 9;17:1297325. doi: 10.3389/fnhum.2023.1297325. eCollection 2023.
- Background: PubMed 38841121Jenkins DD, Garner SS, Brennan A, Morris J, Bonham K, Adams L, Hunt S, Moss H, Badran BW, George MS, Wiest DB. Transcutaneous auricular vagus nerve stimulation may benefit from the addition of N-acetylcysteine to facilitate motor learning in infants of diabetic mothers failing oral feeds. Front Hum Neurosci. 2024 May 22;18:1373543. doi: 10.3389/fnhum.2024.1373543. eCollection 2024.
- Individual participant dataSharing planned: Yes. We will preserve and share the subject level feeding, heart rate, and developmental test data with unique identifiers. The individual MRI scans will be preserved in Dicom and .rda format; and the VFSS in video files with same unique, coded identifiers.
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.
Dorothea D JENKINS, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing taVNS, NAC and taVNS and inactive taVNS in people with Feeding Delays and Neonates and Term Infants, 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 5 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: looking for participants now, as of the sponsor's last update on 21 Nov 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorothea D Jenkins, MD (843-792-2112, jenkd@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants at full oral feeds (time frame: 24 days). The study lists 2 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 NCT07049952, which also lists 11 linked publications.
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 21 Nov 2025.