52 Participants Needed

Neurostimulation for Neonatal Opioid Withdrawal Syndrome

(SPROUT Trial)

Recruiting at 2 trial locations
NK
CB
Overseen ByCaroline Benner
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Spark Biomedical, Inc.
Must be taking: Morphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Transcutaneous auricular neurostimulation (tAN) has been tested in infants with neonatal opioid withdrawal syndrome and was found to be well-tolerated with no unexpected side effects. This suggests that tAN is generally safe for use in humans.12367

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

My newborn is opioid-dependent due to severe illness or injury but is stable.
My baby is over 33 weeks old, has withdrawal symptoms, and needs morphine.
I am breathing on my own or with minimal help.
See 1 more

Exclusion Criteria

My infant needs a lot of help with breathing.
Newborns who have withdrawal symptoms due to medication given to the mother during pregnancy will be excluded.
My newborn has been given methadone more than 6 times or for over 24 hours.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Neonates receive either active or sham tAN therapy along with morphine, with FNASS scoring every three hours

Up to 4 weeks
Continuous inpatient monitoring

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

24 months
4 follow-up contacts

Treatment Details

Interventions

  • Roo tAN Therapy System
  • Sham Roo tAN Therapy System
  • Sham Sparrow Fledging Therapy System
  • Sparrow Fledging Therapy System
Trial Overview The study tests if the Sparrow Fledging Therapy System (a type of neurostimulation therapy) can reduce how much oral morphine a baby needs after treatment starts compared to a sham system. The goal is to see if this therapy helps manage withdrawal symptoms more effectively in infants with NOWS.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tAN + MorphineExperimental Treatment1 Intervention
Group II: Sham tAN + MorphinePlacebo Group1 Intervention

Roo tAN Therapy System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Roo System for:
  • Neonatal Opioid Withdrawal Syndrome (NOWS)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spark Biomedical, Inc.

Lead Sponsor

Trials
14
Recruited
560+

University of Texas Health Science Center San Antonio

Collaborator

Trials
1
Recruited
50+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

University of Texas Southwestern Medical Center

Collaborator

Trials
1,102
Recruited
1,077,000+

Findings from Research

Transcutaneous auricular neurostimulation (tAN) is a safe and well-tolerated treatment for infants with neonatal opioid withdrawal syndrome (NOWS), showing no unexpected adverse effects during the trial.
In this study involving eight infants, tAN significantly reduced the average length of oral morphine treatment from the national average of 23 days to 13.3 days, suggesting it may be an effective non-opioid adjuvant therapy for NOWS.
Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome.Jenkins, DD., Khodaparast, N., O'Leary, GH., et al.[2022]
Transcutaneous auricular neurostimulation (tAN) significantly reduced opioid withdrawal symptoms, with a mean decrease of 7.0 points on the Clinical Opiate Withdrawal Scale (COWS) after 60 minutes of treatment, indicating a 45.9% reduction in symptoms.
The study demonstrated that tAN is a safe and effective non-opioid treatment for managing opioid withdrawal syndrome, achieving up to a 74.7% reduction in COWS scores over a 5-day period, supporting its FDA clearance.
Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial.Tirado, CF., Washburn, SN., Covalin, A., et al.[2022]
A feasibility study involving 12 participants demonstrated that auricular acupressure can be effectively integrated into the standard care for neonatal opioid withdrawal syndrome (NOWS), with 100% adherence to the treatment protocol by nurse practitioners.
Mothers reported high satisfaction with the acupressure treatment (mean scores of 3.8-4.0 out of 4.0), and a majority of healthcare providers expressed support for the method, indicating a positive reception for this non-pharmacologic approach.
Feasibility of auricular acupressure as an adjunct treatment for neonatal opioid withdrawal syndrome (NOWS).Jackson, HJ., Lopez, C., Miller, S., et al.[2022]

References

Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome. [2022]
Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. [2022]
Feasibility of auricular acupressure as an adjunct treatment for neonatal opioid withdrawal syndrome (NOWS). [2022]
Trans-cranial electrical stimulation attenuates the severity of naloxone-precipitated morphine withdrawal in rats. [2019]
Comparative effectiveness of opioid replacement agents for neonatal opioid withdrawal syndrome: a systematic review and meta-analysis. [2022]
Auricular neural stimulation as a new non-invasive treatment for opioid detoxification. [2021]
A Scoping Review of Acupuncture as a Potential Intervention for Neonatal Abstinence Syndrome. [2020]
Standard Fixed-Schedule Methadone Taper Versus Symptom-Triggered Methadone Approach for Treatment of Neonatal Opioid Withdrawal Syndrome. [2020]
Opioid Neonatal Abstinence Syndrome: An Overview. [2019]
Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study. [2022]