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NCT04643808 · ClinicalTrials.gov registry record · Early Phase 1
taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds
A Early Phase 1 study of Infant Development and Vagus Nerve Stimulation, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT04643808: Completed Early Phase 1 study of Infant Development and Vagus Nerve Stimulation, sponsored by Medical University of South Carolina.
NCT04643808 is a Early Phase 1 study of Infant Development and Vagus Nerve Stimulation that has completed, run by Medical University of South Carolina. The registered enrollment target is 35 participants, below the 402-participant average among 30 other Infant Development trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04643808, a Early Phase 1 study of Infant Development and Vagus Nerve Stimulation, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke. This study is designed to investigate whether transcutaneous auricular VNS (taVNS) paired with oromotor rehabilitation is tolerable, safe, and facilitates motor learning in infants who have failed oral feeding.
Primary Outcome
Number of infants who maintained full daily PO intake for 4 days (\>120 ml/kg/day) and gained weight adequate for discharge (\>20 g/day) were classified as 'Responders'.
Conditions Studied
Interventions
- DEVICE transcutaneous auricular vagus nerve stimulation
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2022-07-01 |
| Phase | Early Phase 1 |
What the finished NCT04643808 record still lists
NCT04643808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 402-participant average among 30 other Infant Development trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Infant Development appearing as the primary indexed condition, and to 1 intervention - of which transcutaneous auricular vagus nerve stimulation is the first listed.
NCT04643808 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04643808 about?
NCT04643808 is a clinical study titled "taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds". Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke. This study is designed to investigate whether transcutaneous auricular VNS (taV...
What is the current status of trial NCT04643808?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2017-10-01. Estimated completion is 2022-07-01.
What conditions does trial NCT04643808 study?
This clinical trial studies the following conditions: Infant Development, Vagus Nerve Stimulation, Poor Feeding.
What interventions are being tested in trial NCT04643808?
The interventions under investigation include: transcutaneous auricular vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT04643808?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04643808 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04643808's enrollment target sits among peer trials
35 29th of 30 higher than 2 of 30 other Infant Development trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infant Development 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.
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