What side effects are associated with this type of intervention?

Common treatments for Neonatal Opioid Withdrawal Syndrome (NOWS) include pharmacologic interventions like morphine and methadone, which can have side effects such as respiratory depression, feeding difficulties, and prolonged hospital stays. Non-pharmacologic treatments, including neuromodulation therapies like Transcutaneous Auricular Neurostimulation (tAN), are being studied for their potential benefits. Similar neuromodulation therapies, such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), have reported mild side effects including tingling, redness, and muscle spasms, but no serious adverse events. These therapies aim to modulate neural pathways to reduce pain or withdrawal symptoms, offering a promising alternative with potentially fewer side effects compared to traditional pharmacologic treatments.

What prior FDA approvals exist?

Currently, the primary FDA-approved treatments for Neonatal Opioid Withdrawal Syndrome (NOWS) involve the use of medications such as morphine and methadone to manage withdrawal symptoms. These treatments focus on opioid replacement to gradually wean infants off dependence. While tAN therapy (Transcutaneous Auricular Neurostimulation) is being studied for its potential to modulate neural pathways and reduce withdrawal symptoms, there are no FDA-approved neurostimulation treatments for NOWS at this time. The research into tAN therapy represents a novel approach that could complement or provide an alternative to existing pharmacologic treatments.

What other types of research exist?

Promising alternatives to tAN therapy for NOWS patients include transcutaneous electrical nerve stimulation (TENS), which has shown efficacy in pain relief and could potentially be adapted for neonatal use. Additionally, transcranial magnetic stimulation (TMS) has been effective in reducing headache days and may offer benefits for withdrawal symptoms. Acupuncture, particularly electroacupuncture, has demonstrated analgesic effects and could be explored as a complementary therapy. These alternatives leverage neurostimulation and non-pharmacological approaches, aligning with the goals of tAN therapy.

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Neurostimulation

Neurostimulation for Neonatal Opioid Withdrawal Syndrome (SPROUT Trial)

N/A

Recruiting

Research Sponsored by Spark Biomedical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neonates or infants >33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy

Clinically stable or on minimal respiratory support (continuous positive airway pressure [CPAP], nasal cannula, or room air)

Must not have

Unstable infants or those requiring significant respiratory support

Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3, 9, 18, and 24 months of age

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't detailed here as it's a non-pharmacological intervention, potential risks may include discomfort from wearing the device or skin irritation where it attaches. There could also be unknown risks due to the novel nature of this therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby is over 33 weeks old, has withdrawal symptoms, and needs morphine.

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I am breathing on my own or with minimal help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant needs a lot of help with breathing.

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My newborn has been given methadone more than 6 times or for over 24 hours.

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My child is under state guardianship.

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I have major birth defects affecting my heart or lungs that haven't been fixed.

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My ear shape prevents certain devices from fitting properly.

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I have been diagnosed with cardiomyopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3, 9, 18, and 24 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3, 9, 18, and 24 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 9, 18, and 24 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Finnegan Neonatal Abstinence Scoring System (FNASS)

Secondary study objectives

Mean number of days from birth to medical readiness for discharge

Median length of hospital stay due to NOWS

Median length of hospital stay secondary to NOWS

+1 more

Other study objectives

Neonatal Infant Pain Scale (NIPS)

Number of infants who have scores outside of "typical performance", as calculated by a score greater than 1 standard deviation away from the mean, on the Sensory Profile 2 (SP-2)

Number of infants with an Ages and Stages Questionnaire-3 (ASQ-3) Score greater than 2 standard deviations below the mean for any domain

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tAN + MorphineExperimental Treatment1 Intervention

Group II: Sham tAN + MorphinePlacebo Group1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neonatal Opioid Withdrawal Syndrome (NOWS) include pharmacological interventions like morphine and non-pharmacological approaches such as Transcutaneous Auricular Neurostimulation (tAN). tAN therapy likely modulates neural pathways by stimulating specific nerves in the ear, such as the auricular branch of the vagus nerve and the auriculotemporal nerve, to reduce pain and withdrawal symptoms. This matters for NOWS patients as it offers a non-pharmacological option that can potentially minimize the use of opioid medications, thereby reducing associated risks and side effects.

Transcranial electrical stimulation with Limoge's currents decreases halothane requirements in rats. Evidence for the involvement of endogenous opioids.Electroacupuncture suppresses a nociceptive reflex: naltrexone prevents but does not reverse this effect.Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome.