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BabySTrong II taVNS Feeding Trial

Study acronym: BabySTrong II
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 1, 2025 to Nov 16, 2025 · Site details revisedv7 Show 2 more changesShow less
    • Start date changed from estimate of Nov 1, 2025 to Nov 16, 2025
    • Site details revised
  2. Start date: Oct 1, 2025 to Nov 1, 2025v6
  3. Primary completion date: Mar 1, 2027 to Apr 1, 2027 Start date: Sep 15, 2025 to Oct 1, 2025v5 Show 1 more changeShow less
    • Start date: Sep 15, 2025 to Oct 1, 2025
  4. Start date: Jul 21, 2025 to Sep 15, 2025 Primary completion date: Dec 31, 2026 to Mar 1, 2027 · Completion date: Aug 30, 2027 to Dec 30, 2027v4 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2026 to Mar 1, 2027
    • Completion date: Aug 30, 2027 to Dec 30, 2027
  5. Collaborators: 2 to 1v3 See this version in full on ClinicalTrials.gov ↗
  6. Primary endpoints revised (2) Interventions: N-Acetyl Cysteine (NAC) and taVNS (transcutaneous auricular vagus nerve stimulation) (Combination Product), inactive transcutaneous… to NAC and taVNS (Combination Product), inactive taVNS (Device), sterile water and inactive taVNS (Combination Product), taVNS (Device) · Secondary endpoints: details revised at 1 of 2 entries · Study description shortened, about 17 wordsv2 Show 3 more changesShow less
    • Interventions: N-Acetyl Cysteine (NAC) and taVNS (transcutaneous auricular vagus nerve stimulation) (Combination Product), inactive transcutaneous… to NAC and taVNS (Combination Product), inactive taVNS (Device), sterile water and inactive taVNS (Combination Product), taVNS (Device)
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07049952
Lead Sponsor Medical University of South Carolina
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Feeding Delays, Neonates and Term Infants
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov