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NCT04588519 · ClinicalTrials.gov registry record · NA
tAN to Mitigate Withdrawal Behaviors in Neonates
A NA study, sponsored by Spark Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT04588519 is a NA study that has completed, run by Spark Biomedical. The registered enrollment target is 8 participants.
The verdict
NCT04588519, a NA study, has completed, sponsored by Spark Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether. Reducing Neonatal Opioid Withdrawal Syndrome (NOWS) symptoms may also help lessen or eliminate the need for opioid medication and shorten the length of the hospital stay. The neurostimulation device, currently called the Roo is a safe form of neurostimulation that uses sticker-like patches worn in and around the ear during the withdrawal period. The patches deliver a small and painless current of electrical pulses to the skin and underlying cranial nerves.
Interventions
- DEVICE Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-05-30 |
| Est. Completion | 2020-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04588519
The ClinicalTrials.gov registry entry for NCT04588519 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spark Biomedical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System is the first listed.
NCT04588519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04588519 about?
NCT04588519 is a clinical study titled "tAN to Mitigate Withdrawal Behaviors in Neonates". This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether. Reducing Neonatal Opioid Withdrawal Syndrome (NOWS) symptoms may also help lessen...
What is the current status of trial NCT04588519?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2020-05-30. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT04588519?
The interventions under investigation include: Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System (DEVICE).
Who is sponsoring clinical trial NCT04588519?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
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