BabySTrong II taVNS Feeding Trial

NCT07049952 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: WCG 20250610R42HD104409
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7days / 10days

Secondary Outcomes (2)

• time to full oral feeds

  24 days

• Neuroplasticity via DKI

  14 days

Study Arms (4)

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

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.

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.

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.

Combination Product: sterile water and inactive taVNS

Interventions

taVNS DEVICE

Active or inactive non-invasive vagus nerve stimulation of the auricular branch of the vagus nerve paired with 2 oral feedings/day for 14d

Non-IDM active taVNS

NAC and taVNS COMBINATION_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).

IDM NAC and active taVNS

inactive taVNS DEVICE

inactive transcutaneous auricular vagus nerve stimulation with 2 feeds/day x 14 days

Non-IDM Control

sterile water and inactive taVNS COMBINATION_PRODUCT

Sterile water per NG tube every 6h for 4 days, then continuing with 14days of inactive taVNS paired with oral feeding

IDM Control

Eligibility Criteria

• Age: 39 Weeks - 54 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shawn Jenkins Children's Hospital, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 29361441 BACKGROUND

• Badran 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.

  PMID: 29716843 BACKGROUND

• Badran 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.

  PMID: 30146041 BACKGROUND

• Moss 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.

  PMID: 29561203 BACKGROUND

• Badran 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.

  PMID: 29895444 BACKGROUND

• Badran 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.

  PMID: 30663712 BACKGROUND

• Badran 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.

  PMID: 32256328 BACKGROUND

• Aljuhani 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.

  PMID: 36093716 BACKGROUND

• Jenkins 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.

  PMID: 37329979 BACKGROUND

• Aljuhani 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.

  PMID: 38021221 BACKGROUND

• Jenkins 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.

  PMID: 38841121 BACKGROUND

Study Officials

• Dorothea D JENKINS, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorothea D Jenkins, MD

CONTACT

843-792-2112; jenkd@musc.edu

Gary Connor, RN

CONTACT

207-281-2652; gconnor@asclepiusresearch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: parent
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: November 16, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: data associated with a publication no later than the date of publication and all data at the end of the award and any NCE; DASH will control the end date for availability
• Access Criteria: IPD will be placed in DASH, a controlled access data repository at NICHD. To request access of the data, researchers will use the standard processes, and the DASH Data Access Committee will decide which requests to grant.

Locations

US (1)