NCT07049952: BabySTrong II

BabySTrong II taVNS Feeding Trial

Recruiting now Phase 2, PHASE3 Last updated 21 November 2025

What this trial tests

Phase 2, PHASE3 trial testing taVNS in Feeding Delays in 88 participants. Currently enrolling.

Timeline

16 November 2025

Primary endpoint
1 April 2027

30 December 2027

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	88
Start date	16 November 2025
Primary completion	1 April 2027
Estimated completion	30 December 2027
Sites	1 location across United States

Drugs / interventions tested

• taVNS
• NAC and taVNS
• inactive taVNS
• sterile water and inactive taVNS

Conditions studied

• Feeding Delays — all drugs for Feeding Delays →
• Neonates and Term Infants — all drugs for Neonates and Term Infants →

Sponsor

Medical University of South Carolina

Who can join

Adults 39 Weeks to 54 Weeks, any sex, with Feeding Delays or Neonates and Term Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.