Actively Recruiting
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Led by Milton S. Hershey Medical Center · Updated on 2026-02-10
50
Participants Needed
1
Research Sites
377 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns at least 35 weeks gestation with chronic in-utero opioid exposure for over 1 month
- Neonates born at Penn State Hershey Medical Center or transferred there within 48 hours after birth
- Mothers with chronic opioid use during pregnancy for at least 1 month
You will not qualify if you...
- Born before 35 weeks gestation
- Infant requiring mechanical ventilation or non-invasive respiratory support
- Infant exposed to magnesium sulfate
- Opioid-exposed neonates receiving dextrose infusion for persistent hypoglycemia within 48 hours after birth
- Infant with major congenital anomalies
- Parent or guardian unable to provide consent
- Mothers and neonates without history of opioid exposure or dependence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
R
Rhea E Sullivan, B.S.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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