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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 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04632069
The ClinicalTrials.gov registry entry for NCT04632069 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 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 0 conditions, and to 1 intervention - of which N acetyl cysteine + vagus nerve stimulation is the first listed.
NCT04632069 reports 0 study locations.
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.
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