NCT05937594 MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
| NCT ID | NCT05937594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Neonatal Opioid Withdrawal Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-01-15 |
| Primary Completion | 2026-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-01-15 with a primary completion date of 2026-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Newborns ≥35weeks gestation with chronic in-utero opioid exposure (\>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care * Neonates born at Penn State Hershey Medical Center or transferred at \<48 hours after birth * Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation) 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
Contact & Investigator
Steven D. Hicks, MD, PhD
PRINCIPAL INVESTIGATOR
Associate Professor of Pediatrics
Frequently Asked Questions
Who can join the NCT05937594 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 5 Days, studying Neonatal Opioid Withdrawal Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05937594 currently recruiting?
Yes, NCT05937594 is actively recruiting participants. Contact the research team at rsullivan2@pennstatehealth.psu.edu for enrollment information.
Where is the NCT05937594 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT05937594 clinical trial?
NCT05937594 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Steven D. Hicks, MD, PhD at Associate Professor of Pediatrics. The trial plans to enroll 50 participants.