BabySTrong II taVNS Feeding 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. 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

Interventions

DEVICE

taVNS

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

COMBINATION_PRODUCT

NAC and taVNS

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).

DEVICE

inactive taVNS

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

COMBINATION_PRODUCT

sterile water and inactive taVNS

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Dorothea D JENKINS, MD · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

39 Weeks

Max Age

54 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-16

Primary Completion

2027-04-01

Completion

2027-12-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations