Neurostimulation for Neonatal Opioid Withdrawal Syndrome
(SPROUT Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Spark Biomedical, Inc.
No Placebo Group
Approved in 1 jurisdiction
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.
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.
12345What 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.
12367Is 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.
128910Eligibility 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.
+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.
+7 more
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Medical University of South Carolina - Shawn Jenkins Children's HospitalCharleston, SC
UT Southwestern Medical Center / Parkland Memorial HospitalDallas, TX
University of Texas Health Science Center San AntonioSan Antonio, TX
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Who Is Running the Clinical Trial?
Spark Biomedical, Inc.Lead Sponsor
University of Texas Health Science Center San AntonioCollaborator
Medical University of South CarolinaCollaborator
University of Texas Southwestern Medical CenterCollaborator
References
Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome. [2022]Maternal opioid use during pregnancy is a growing national problem and can lead to newborns developing neonatal opioid withdrawal syndrome (NOWS) soon after birth. Recent data demonstrates that nearly every 15 min a baby is born in the United States suffering from NOWS. The primary treatment for NOWS is opioid replacement therapy, commonly oral morphine, which has neurotoxic effects on the developing brain. There is an urgent need for non-opioid treatments for NOWS. Transcutaneous auricular neurostimulation (tAN), a novel and non-invasive form of electrostimulation, may serve as a promising alternative to morphine. tAN is delivered via a multichannel earpiece electrode worn on and around the left ear, targeting two cranial nerves-the vagus and trigeminal nerves. Prior research suggests that auricular neurostimulation exerts an anxiolytic effect on the body by releasing endogenous opioids and reduces withdrawal symptoms in adults actively withdrawing from opioids. In this first-in-human prospective, open-label trial, we investigated tAN as an adjuvant to morphine therapy in eight infants >33 weeks gestational age suffering from NOWS and receiving oral morphine treatment. Infants received tAN for 30 min 1 h before receiving a morphine dose. tAN was delivered at 0.1 mA below perception intensity at two different nerve targets on the ear: Region 1, the auricular branch of the vagus nerve; and Region 2, the auriculotemporal nerve. tAN was delivered up to four times daily for a maximum of 12 days. The primary outcome measures were safety [heart rate monitoring, Neonatal Infant Pain Scale (NIPS), and skin irritation] and morphine length of treatment (LOT). tAN was well-tolerated and resulted in no unanticipated adverse events. Comparing to the national average of 23 days, the average oral morphine LOT was 13.3 days (median 9 days) and the average LOT after tAN initiation was 7 days (median 6 days). These preliminary data suggest that tAN is safe and may serve as a promising alternative adjuvant for treating NOWS and reducing the amount of time an infant receives oral morphine.
Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. [2022]As pharmacological treatments are the primary option for opioid use disorder, neuromodulation has recently demonstrated efficacy in managing opioid withdrawal syndrome (OWS). This study investigated the safety and effectiveness of transcutaneous auricular neurostimulation (tAN) for managing OWS.
Feasibility of auricular acupressure as an adjunct treatment for neonatal opioid withdrawal syndrome (NOWS). [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">The opioid epidemic in the United States continues to threaten public health. As a result of this crisis, neonatal opioid withdrawal syndrome (NOWS) has risen exponentially and requires a multitude of non-pharmacologic treatments to ensure healthy neonatal outcomes. Methods: This feasibility study implemented an acupressure protocol as informed by the Near-Term Infant (NTI) conceptual framework for the treatment of NOWS. Aims of this study were to assess provider training, effective integration of acupressure within the standard of care, and acceptance of this treatment by mothers and healthcare providers. Results: With maternal consent, a total of 12 participants were enrolled and underwent auricular acupressure. Nurse Practitioners were credentialed (75%) and effectively administered neonatal acupressure (100%) in accordance with the study protocol. Mothers were very satisfied with acupressure for the treatment of NOWS (Client Satisfaction Questionaire-8 mean scores 3.8-4.0 of a possible 4.0), and the majority of healthcare providers were supportive (66%, mean scores 3.6 to 4.0 out of possible 5). Conclusions: Auricular acupressure was successfully implemented within the standard of care for NOWS. Future studies should incorporate outlined suggestions and include qualitative measures of acceptance as well as randomized controlled trials to evaluate efficacy.
Trans-cranial electrical stimulation attenuates the severity of naloxone-precipitated morphine withdrawal in rats. [2019]The expression of morphine withdrawal in rats has been demonstrated as dependent upon the integrity of specific brain regions. Focal intracranial electrical stimulation of some of these sites results in the attenuation of withdrawal severity. The present study demonstrates that electrical auricular stimulation, in a paradigm known to attenuate nociceptive responses of several brain nuclei, attenuates the severity of naloxone-precipitated morphine withdrawal in rats. This simple non-invasive treatment, based on long-standing principles of electroacupuncture, may provide a useful adjunct for therapy of the narcotic withdrawal syndrome.
Comparative effectiveness of opioid replacement agents for neonatal opioid withdrawal syndrome: a systematic review and meta-analysis. [2022]To compare short-term treatment outcomes of opioid pharmacotherapy for neonatal opioid withdrawal syndrome (NOWS).
Auricular neural stimulation as a new non-invasive treatment for opioid detoxification. [2021]The recent opioid crisis is one of the rising challenges in the history of modern health care. New and effective treatment modalities with less adverse effects to alleviate and manage this modern epidemic are critically needed. The FDA has recently approved two non-invasive electrical nerve stimulators for the adjunct treatment of symptoms of acute opioid withdrawal. These devices, placed behind the ear, stimulate certain cranial nerves with auricular projections. This neural stimulation reportedly generates a prompt effect in terms of alleviation of withdrawal symptoms resulting from acute discontinuation of opioid use. Current experimental evidence indicates that this type of non-invasive neural stimulation has excellent potential to supplement medication assisted treatment in opioid detoxification with lower side effects and increased adherence to treatment. Here, we review current findings supporting the use of non-invasive neural stimulation in detoxification from opioid use. We briefly outline the neurophysiology underlying this approach of auricular electrical neural stimulation and its role in enhancing medication assisted treatment in treating symptoms of opioid withdrawal. Considering the growing deleterious impact of addictive disorders on our society, further studies on this emerging treatment modality are warranted.
A Scoping Review of Acupuncture as a Potential Intervention for Neonatal Abstinence Syndrome. [2020]Objective: Neonatal abstinence syndrome (NAS) has risen drastically over the past decade. Infants with NAS experience extreme discomfort and developmental delays when going into withdrawal. Management includes multiple supportive and nonpharmacologic therapies as first-line treatments in an effort to reduce or prevent the need for medication management. Acupuncture has demonstrated efficacy in adults experiencing withdrawal from addictions, as well as for treating many other conditions in pediatric patients who have similar symptoms to withdrawal. The purpose of this review is to evaluate the safety and efficacy of acupuncture for neonates in withdrawal. Materials and Methods: This review was guided by the Arksey and O'Malley methodological framework, and analysis was performed based on a social ecological model. The PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-Analyses] statement was used to organize selected publications, and a flow chart was created to display the search process. PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Databases were searched for relevant publications. Results: Acupuncture appears to be safe and effective for reducing withdrawal symptoms in infants, and, thus, should be considered as an additional nonpharmacologic treatment option for NAS.
Standard Fixed-Schedule Methadone Taper Versus Symptom-Triggered Methadone Approach for Treatment of Neonatal Opioid Withdrawal Syndrome. [2020]We compared hospitalization outcomes in infants with neonatal opioid withdrawal syndrome (NOWS) treated with a novel symptom-triggered methadone approach (STMA) versus a fixed-schedule methadone taper (FSMT).
Opioid Neonatal Abstinence Syndrome: An Overview. [2019]Opioid neonatal abstinence syndrome (NAS) refers to signs of withdrawal observed in infants experiencing intrauterine opioid exposures. Early identification of at-risk infants allows for the prompt initiation of nonpharmacologic supportive care. When withdrawal symptoms are severe despite these interventions, pharmacologic therapy including opioid weaning is initiated. Consistency with standardized nonpharmacologic approaches as well as stringent weaning protocols are important in minimizing the length of stay and length of pharmacologic treatment for these vulnerable patients.
Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study. [2022]Neonatal Opioid Withdrawal Syndrome (NOWS) is a significant public health issue and while millions of neonates are affected each year, an optimal pharmacologic weaning protocol has yet to be demonstrated. In this study, we compare hospital length of stay (LOS) and length of treatment (LOT) for treatment of neonatal opioid withdrawal (NOWS) with morphine versus methadone.