Neurostimulation for Neonatal Opioid Withdrawal Syndrome
(SPROUT Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing if a small device that sends electrical signals to the ear can help reduce the need for morphine in infants experiencing withdrawal symptoms from opioid exposure. The device has the potential to help with treatment while causing fewer side effects and improving adherence.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if participants must stop taking their current medications. However, since the trial involves infants with Neonatal Opioid Withdrawal Syndrome, it is likely that they will continue their current morphine treatment as part of the study.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It focuses on infants with Neonatal Opioid Withdrawal Syndrome who are already receiving morphine therapy.
What data supports the idea that Neurostimulation for Neonatal Opioid Withdrawal Syndrome is an effective treatment?
The available research shows that Neurostimulation, specifically Transcutaneous Auricular Neurostimulation (tAN), can be an effective treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). In a study involving eight infants, tAN was used alongside the usual morphine treatment. The results showed that the average time infants needed morphine was reduced from the national average of 23 days to just 13.3 days, with some infants needing as little as 7 days after starting tAN. This suggests that tAN helps reduce the time infants need to be on morphine, making it a promising alternative treatment. Additionally, tAN was found to be safe, with no unexpected side effects. Compared to other treatments like auricular acupressure, which was well-received but lacked specific data on reducing treatment time, tAN shows more concrete evidence of effectiveness in reducing the duration of drug treatment.12345
What data supports the effectiveness of the treatment for neonatal opioid withdrawal syndrome?
Research suggests that transcutaneous auricular neurostimulation (tAN) is a promising treatment for neonatal opioid withdrawal syndrome (NOWS). In a study, infants receiving tAN alongside morphine had a shorter average treatment duration with morphine compared to the national average, indicating that tAN may help reduce the time infants need opioid medication.12345
What safety data exists for neurostimulation treatment in neonatal opioid withdrawal?
The safety data for transcutaneous auricular neurostimulation (tAN) in treating neonatal opioid withdrawal syndrome (NOWS) indicates that it is well-tolerated with no unanticipated adverse events. In a study involving eight infants, tAN was used as an adjuvant to morphine therapy and showed a reduction in the length of morphine treatment. The treatment was delivered up to four times daily for a maximum of 12 days, and safety was monitored through heart rate, pain scale, and skin irritation assessments. These findings suggest that tAN is a safe alternative for managing NOWS.12367
Is transcutaneous auricular neurostimulation (tAN) safe for humans?
Is the Roo tAN Therapy System a promising treatment for babies with Neonatal Opioid Withdrawal Syndrome?
Yes, the Roo tAN Therapy System is a promising treatment for babies with Neonatal Opioid Withdrawal Syndrome. It is a non-invasive method that helps reduce the time babies need to be on morphine, a common drug used for treatment. This therapy is safe and may help lessen withdrawal symptoms by stimulating nerves in the ear, potentially offering a better alternative to traditional drug treatments.128910
How is the Roo tAN Therapy System treatment different from other treatments for neonatal opioid withdrawal syndrome?
The Roo tAN Therapy System is unique because it uses a non-invasive method called transcutaneous auricular neurostimulation (tAN), which involves a special earpiece that stimulates nerves in the ear to help reduce withdrawal symptoms, unlike traditional treatments that rely on opioid medications like morphine.128910
Eligibility Criteria
This trial is for newborns over 33 weeks gestational age with Neonatal Opioid Withdrawal Syndrome (NOWS) needing morphine therapy, who are either breathing on their own or have minimal respiratory support. It includes those stable after severe illness or brain injury but excludes very unstable infants, those with significant heart issues, abnormal ear anatomy, major congenital anomalies affecting breathing or circulation, wards of the state, and older than two weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Treatment
Neonates receive either active or sham tAN therapy along with morphine, with FNASS scoring every three hours
Neurodevelopmental Follow-up
Participants' neurodevelopment is assessed at 3, 9, 18, and 24 months using ASQ-3 and SP-2; further assessment with BSID-III if needed
Treatment Details
Interventions
- Roo tAN Therapy System
- Sham Roo tAN Therapy System
- Sham Sparrow Fledging Therapy System
- Sparrow Fledging Therapy System
Roo tAN Therapy System is already approved in United States for the following indications:
- Neonatal Opioid Withdrawal Syndrome (NOWS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spark Biomedical, Inc.
Lead Sponsor
University of Texas Health Science Center San Antonio
Collaborator
Medical University of South Carolina
Collaborator
University of Texas Southwestern Medical Center
Collaborator