tAN to Mitigate Withdrawal Behaviors in Neonates

NCT04588519 | Completed Results FDA Device

• 2 other identifiers: Pro000909601R43DA050360-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With no Adverse Events Related to Bradycardia (HR < 80 Bpm), Worsening of Swallowing or Feeding, Skin Irritation, or Elevation of Neonatal Infant Pain Scores.

  No adverse events of bradycardia (HR \< 80 bpm), worsening of swallowing or feeding, skin irritation, or elevation of Neonatal Infant Pain Scores.

  12 days

• Mean Finnegan Scores During Days of tAN Sessions

  The Finnegan Scale assesses 31 of the most common signs of neonatal drug withdrawal syndrome and is scored on the basis of pathological significance and severity of the adverse symptoms. Scores for each sign are added to obtain a total score. Total scores range from 0-20, where lower scores are indicative of less severe signs of neonatal drug withdrawal symptoms.

  12 days

Secondary Outcomes (2)

• Duration of Morphine Weaning

  12 days

• Length of Hospital Stay

  From participant birth to hospital discharge, a median of 17 days

Study Arms (1)

Active Transcutaneous Auricular Neurostimulation

EXPERIMENTAL

Transcutaneous Auricular Neurostimulation programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA

Device: Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System

Interventions

Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System DEVICE

Spark Roo tAN System programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.

Active Transcutaneous Auricular Neurostimulation

Eligibility Criteria

• Age: 33 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates or infants with opioid withdrawal or Neonatal Abstinence Syndrome (NAS) who have withdrawal scores requiring morphine replacement therapy. They must be clinically stable, on minimal respiratory support (Continuous positive airway pressure (CPAP), nasal cannula, or room air), \>33 weeks gestational age at enrollment, and currently receiving replacement therapy for opioid dependence.
• Stable neonates who are dependent on opioids, such as after extracorporeal membrane oxygenation, severe illness or brain injury, will be included in this study, as these neonates represent a population in which tAN could minimize withdrawal while not adding to burden of pharmacotherapies. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies.

You may not qualify if:

• Unstable infants or those requiring significant respiratory support.
• Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving \*
• Infants \<33weeks gestation at enrollment.
• Major unrepaired congenital anomalies
• Cardiomyopathy \*Preterm infants commonly have short periods of shallow or absent breathing or lower heart rate termed apnea and bradycardia, respectively, and most are being treated for these physiologic manifestations of prematurity with caffeine, an effective central stimulant. Infants are on cardiorespiratory monitors through the nursery stay with recording devices to capture events and play them back. However, nearly all of these events are self resolving, meaning the infant resolves the breathing pause or bradycardia on their own. Infants who require repeated episodes of stimulation to come out of these events are defined as unstable. Similarly, infants on significant respiratory support are not stable, and will not be eligible.

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

This trial was open-label with no sham control group, limiting interpretation of the study results in terms of the placebo effect and true effect. An RCT would further address additional study limitations, namely the small sample size and conduct and a single center. The inclusion of infants at different durations of morphine therapy does not allow for interpretation of the potential effect of tAN during early administration of morphine therapy.

Results Point of Contact

• Title: Navid Khodaparast, PhD
• Organization: Spark Biomedical, Inc.

navid.khodaparast@sparkbiomedical.com

832-280-4756

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: May 30, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)