N/A
N=8
tAN to Mitigate Withdrawal Behaviors in Neonates
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04588519 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: 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. — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Spark Biomedical, Inc.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
7 | — |
| PRIMARY Mean Finnegan Scores During Days of tAN Sessions |
6.33 | — |
| SECONDARY Duration of Morphine Weaning |
6.0 | — |
| SECONDARY Length of Hospital Stay |
17.0 | — |
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.
Eligibility Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT04588519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.