tAN to Mitigate Withdrawal Behaviors in Neonates

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Transcutaneous Auricular Neurostimulation (tAN) to Mitigate Withdrawal Behaviors in Neonates With Opioid Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588519
• Other study ID #: Pro00090960
• Secondary ID: 1R43DA050360-01
• Status: Completed
• Phase: N/A
• Start date: May 30, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2022
• Source: Spark Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. After obtaining parental consent, tAN is delivered to the left ear in NOWS newborns who are on a stable morphine dose for >12h (control dose), using a disposable, multi-channel (Channel1: auricular branch of the vagus nerve (ABVN); Channel2: ATN) earpiece electrode (Spark Biomedical, Inc). 30-minutes of tAN is delivered one hour prior to scheduled morphine dose, up to four times daily for up to 12 days. The device is programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 milliamps (mA); channel 2: 100 Hz, mean intensity 0.6±0.2 mA. Nurses score the Finnegan Neonatal Abstinence Scoring Tool (FNAST) every 3h after feeding and morphine is weaned every 12h if FNAST scores <8.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 30, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 33 Weeks to 1 Year

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Unstable infants or those requiring significant respiratory support.

2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving *

3. Infants <33weeks gestation at enrollment.

4. Major unrepaired congenital anomalies

5. 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.

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Spark Biomedical, Inc.	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Duration of Morphine Weaning	Defined as the number of days between tAN therapy initiation and morphine discontinuation. A shorter duration of morphine weaning indicates better treatment efficacy.	12 days
Secondary	Length of Hospital Stay	Defined as the number of days between birth and discharge. A shorter length of stay indicates better treatment efficacy.	From participant birth to hospital discharge, a median of 17 days