BabySTrong II taVNS Feeding Trial

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

December 30, 2027

Conditions
Feeding DelaysNeonates 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

Trial Locations (1)

29425

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

All Listed Sponsors
collaborator

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

NIH

lead

Medical University of South Carolina

OTHER

NCT07049952 - BabySTrong II taVNS Feeding Trial | Biotech Hunter | Biotech Hunter