Neurostimulation to Improve NOWS Outcomes (NCT05129020)
Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (11 items).
Location: Medical University of South Carolina - Shawn Jenkins Children's Hospital — Charleston, South Carolina
Age range: 33 Weeks to 1 Year
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria
- Unstable infants
- Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving
- Major unrepaired congenital anomalies impacting respiratory or cardiovascular system
- Cardiomyopathy
- Abnormal ear anatomy preventing the device to fit
- Infants diagnosed with iatrogenic NOWS
- Infants two weeks of age or older (after birth)
- Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing
- Infants who are wards of the state
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Medical University of South Carolina - Shawn Jenkins Children's Hospital — Charleston, South Carolina
- UT Southwestern Medical Center / Parkland Memorial Hospital — Dallas, Texas
- University of Texas Health Science Center San Antonio — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neonatal Opioid Withdrawal Syndrome
- MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome — Hershey, Pennsylvania
- Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome — Birmingham, Alabama
- ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study — Birmingham, Alabama
- Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) — Birmingham, Alabama
Explore by condition: All Neonatal Opioid Withdrawal Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.