BabySTrong II taVNS Feeding Trial

Conditions

• Feeding Delays
• Neonates and Term Infants

Eligibility Criteria

Sex

ALL

Age

39 Weeks - 54 Weeks

Healthy Volunteers

Not accepted

Interventions

• taVNS — DEVICE
  Active or inactive non-invasive vagus nerve stimulation of the auricular branch of the vagus nerve paired with 2 oral feedings/day for 14d
• NAC and taVNS — COMBINATION_PRODUCT
  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).
• inactive taVNS — DEVICE
  inactive transcutaneous auricular vagus nerve stimulation with 2 feeds/day x 14 days
• sterile water and inactive taVNS — COMBINATION_PRODUCT
  Sterile water per NG tube every 6h for 4 days, then continuing with 14days of inactive taVNS paired with oral feeding

Study Details

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.

Key Dates

Start date

Nov 16, 2025

Status verified

Nov 2025

Primary completion

Apr 1, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

88 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Non-IDM active taVNS
  Non-IDM (Infants not product of diabetic mothers) will receive active taVNS with 2 feeds/day x 14 days
• Sham Comparator: Non-IDM Control
  Non-IDM (Infants not product of diabetic mothers) will receive inactive/sham taVNS paired with 2 oral feedings a day for 14 days.
• Active Comparator: IDM NAC and active taVNS
  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.
• Sham Comparator: IDM Control
  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.

Primary Outcome Measure

number of participants at full oral feeds [ Time Frame: 24 days ]

Central Contacts

• Dorothea D Jenkins, MD
  843-792-2112
  [email protected]
• Gary Connor, RN
  207-281-2652
  [email protected]

Locations (1)

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