BabySTrong II taVNS Feeding Trial

Not Applicable

Not yet recruiting

• Conditions: Feeding Delays; Neonates and Term Infants

• Registration Number: NCT07049952
• Lead Sponsor: Medical University of South Carolina

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.

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 Timeline

• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Status Verified: 2025-07
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-21
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of participants at full oral feeds	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	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.

Secondary Outcome Measures

Name	Time	Method
time to full oral feeds	24 days	days to full oral feeds in any taVNS (groups T+NT) vs Control
Neuroplasticity via DKI	14 days	increased mean kurtosis (complexity ) or FA (integrity) in corticospinal tracts in any active taVNS (Groups T+ NT) vs Control groups

Trial Locations

Locations (1)

Shawn Jenkins Children's Hospital, Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States