Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588519
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2020-10-08
Brief Title:
tAN to Mitigate Withdrawal Behaviors in Neonates
Sponsor:
Spark Biomedical Inc
Organization:
Spark Biomedical Inc
Study Overview
Official Title:
Transcutaneous Auricular Neurostimulation tAN to Mitigate Withdrawal Behaviors in Neonates With Opioid Withdrawal
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 After obtaining parental consent tAN is delivered to the left ear in NOWS newborns who are on a stable morphine dose for 12h control dose using a disposable multi-channel Channel1 auricular branch of the vagus nerve ABVN Channel2 ATN earpiece electrode Spark Biomedical Inc 30-minutes of tAN is delivered one hour prior to scheduled morphine dose up to four times daily for up to 12 days The device is programmed to a pulse width of 250ms channel 1 5 Hz mean intensity 0302 milliamps mA channel 2 100 Hz mean intensity 0602 mA Nurses score the Finnegan Neonatal Abstinence Scoring Tool FNAST every 3h after feeding and morphine is weaned every 12h if FNAST scores 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R43DA050360-01 | NIH | None | httpsreporternihgovquickSearch1R43DA050360-01 |