BabySTrong II taVNS Feeding Trial

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Feeding Delays; Neonates and Term Infants

Treatments: Device: inactive taVNS; Combination Product: sterile water and inactive taVNS; Combination Product: NAC and taVNS; Device: taVNS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07049952

WCG 20250610

R42HD104409 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 39 to 54 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups

Non-IDM active taVNS

Active Comparator group

Description:

Non-IDM (Infants not product of diabetic mothers) will receive active taVNS with 2 feeds/day x 14 days

Treatment:

Device: taVNS

Non-IDM Control

Sham Comparator group

Description:

Non-IDM (Infants not product of diabetic mothers) will receive inactive/sham taVNS paired with 2 oral feedings a day for 14 days.

Treatment:

Device: inactive taVNS

IDM NAC and active taVNS

Active Comparator group

Description:

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.

Treatment:

Combination Product: NAC and taVNS

IDM Control

Sham Comparator group

Description:

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.

Treatment:

Combination Product: sterile water and inactive taVNS