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NCT07049952 · ClinicalTrials.gov registry record · Phase 2
BabySTrong II taVNS Feeding Trial
A Phase 2 study of Feeding Delays and Neonates and Term Infants, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT07049952 is a Phase 2 study of Feeding Delays and Neonates and Term Infants that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 88 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07049952, a Phase 2 study of Feeding Delays and Neonates and Term Infants, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 755 total studies on file at ClinicalTrials.gov.
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.
NCT07049952 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
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.
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).
Who is sponsoring clinical trial NCT07049952?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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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