MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome (NCT05937594)
Understanding the microRNA Response to Opioid Withdrawal and Their Uses as Potential Biomarkers for Neonatal Abstinence Syndrome
🩺 Plain-English Summary (8th-Grade Level)
Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this increasingly common medical condition. The proposed study will define the molecular mechanisms that regulate the response to opioid withdrawal in the developing brain by focusing on three candidate microRNAs (let-7a, miR-146a, miR-192) that have been shown to respond to opioid exposure in animal models and adults, and are impacted in both my preliminary study of infants with NAS, and my human neural progenitor cell (NPC) design of opioid withdrawal. By determining the mechanism through which microRNAs impact NPC differentiation in opioid withdrawal, and determining whether exosomal salivary microRNA levels predict treatment dose and neurodevelopmental outcomes in infants with NAS, this study will enhance our knowledge of NAS-related biology and identify potential biomarkers that could improve medical care for this important medical condition.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
Age range: 1 Day to 5 Days
🧪 Interventions in This Study
- Buccal swab saliva for further genetic testing (GENETIC)
📋 "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:
- \<35 week gestation
- Infant required mechanical ventilation or non-invasive mechanical support
- Infant exposure to magnesium sulfate
- Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (\<48hours after birth).
- Infant with major congenital anomalies
- Parent or guardian unable to provide consent
- Mothers and neonates without history of opioid exposure/dependence
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
📞 Contact the Study Coordinator
Phone: (717) 531-0003
Email: rsullivan2@pennstatehealth.psu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- 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
- Neurostimulation to Improve NOWS Outcomes — Charleston, South Carolina
- 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.