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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: Completed NA study, sponsored by Spark Biomedical.
NCT04588519 is a NA study that has completed, run by Spark Biomedical. The registered enrollment target is 8 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
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.
Primary Outcome
No adverse events of bradycardia (HR \< 80 bpm), worsening of swallowing or feeding, skin irritation, or elevation of Neonatal Infant Pain Scores.
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 |
What the finished NCT04588519 record still lists
NCT04588519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 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 1 intervention - of which Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System is the first listed.
NCT04588519 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04588519's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 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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