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NCT04632069 · ClinicalTrials.gov registry record · Early Phase 1
NAC +taVNS in IDM Who Are Poor Oral Feeders
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT04632069: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT04632069 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632069, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired with oral feeding. We propose treating the oxidative stress in IDM infants prior to initiating taVNS, with an FDA-approved antioxidant (N-acetylcysteine, NAC) to improve CNS oxidative stress, which in turn regulates expression of many genes including BDNF, that may enhance motor learning.
Primary Outcome
Difference in the Mean daily change in oral feeding volume(reported in in ml/kg/d) from Day 1-18 days of NAC+taVNS treatment minus Days -14 to 0 (baseline)
Interventions
- COMBINATION_PRODUCT N acetyl cysteine + vagus nerve stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2024-07-01 |
| Phase | Early Phase 1 |
What the finished NCT04632069 record still lists
NCT04632069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which N acetyl cysteine + vagus nerve stimulation is the first listed.
NCT04632069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04632069 about?
NCT04632069 is a clinical study titled "NAC +taVNS in IDM Who Are Poor Oral Feeders". Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired with oral feeding. We propose treating the oxidative stress in IDM inf...
What is the current status of trial NCT04632069?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2021-08-12. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT04632069?
The interventions under investigation include: N acetyl cysteine + vagus nerve stimulation (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04632069?
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 NCT04632069's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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