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BabySTrong II taVNS Feeding Trial
NCT07049952 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE taVNS
- COMBINATION_PRODUCT NAC and taVNS
- DEVICE inactive taVNS
- COMBINATION_PRODUCT sterile water and inactive taVNS
Study Locations (1)
South Carolina
- Shawn Jenkins Children's Hospital, Medical University of South Carolina — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2025-11-16 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07049952
The ClinicalTrials.gov registry entry for NCT07049952 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Feeding Delays appearing as the primary indexed condition, and to 4 interventions — of which taVNS is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07049952 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07049952 about?
NCT07049952 is a clinical study titled "BabySTrong II taVNS Feeding Trial". 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 ...
What is the current status of trial NCT07049952?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2025-11-16. Estimated completion is 2027-12-30.
What conditions does trial NCT07049952 study?
This clinical trial studies the following conditions: Feeding Delays, Neonates and Term Infants. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07049952?
The interventions under investigation include: taVNS (DEVICE), NAC and taVNS (COMBINATION_PRODUCT), inactive taVNS (DEVICE), sterile water and inactive taVNS (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07049952?
This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07049952 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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