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NCT04849507 · ClinicalTrials.gov registry record · NA
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT04849507: Completed NA study, sponsored by Medical University of South Carolina.
NCT04849507 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04849507, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front part of the ear, the BabyStrong feeding system, to delivered transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings daily for 10 days. In an earlier study at Medical University of South Carolina (MUSC), this type of vagus nerve stimulation resulted in more than half of infants who were slated to receive G-tubes, taking full oral feeds by mouth and avoiding a G-tube. In this study some babies will receive the therapy for 10 days and others will get no stimulation. If no progress is made in feeding volumes by day 10, the infants will be switched to the other treatment for 7 days. Parents, study personnel, and care providers will be blinded to taVNS assignment. The electronic stimulation device is Federal Drug Administration (FDA)-cleared for investigational use, and the BabyStrong has been designated a Breakthrough Medical Device by the FDA. This study will be conducted in MUSC's Neonatal Intensive Care Unit.
Primary Outcome
safety : number of participants with episode of Heart rate \< 80beats per minute for 5 seconds, according to the first assigned treatment
Interventions
- DEVICE transcutaneous auricular vagus nerve stimulation
- DEVICE Sham transcutaneous auricular vagus nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2024-08-01 |
| Phase | NA |
What the finished NCT04849507 record still lists
NCT04849507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which transcutaneous auricular vagus nerve stimulation is the first listed.
NCT04849507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04849507 about?
NCT04849507 is a clinical study titled "BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding". Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front pa...
What is the current status of trial NCT04849507?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2022-08-01. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT04849507?
The interventions under investigation include: transcutaneous auricular vagus nerve stimulation (DEVICE), Sham transcutaneous auricular vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT04849507?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04849507's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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