Identifying microRNA biomarkers for infants with opioid withdrawal
Understanding the microRNA Response to Opioid Withdrawal and Their Uses as Potential Biomarkers for Neonatal Abstinence Syndrome
This study is trying to see if certain tiny molecules in the saliva of newborns exposed to opioids can help predict their treatment needs and development outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 5 Days |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05937594 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the molecular mechanisms behind Neonatal Opioid Withdrawal Syndrome (NAS) by focusing on specific microRNAs that respond to opioid exposure. It will involve collecting buccal swab saliva samples from newborns with chronic in-utero opioid exposure to analyze the levels of candidate microRNAs. The study seeks to determine if these microRNA levels can predict treatment needs and neurodevelopmental outcomes in affected infants. By enhancing our understanding of NAS biology, the research aims to improve individualized care for these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns born at or transferred to Penn State Hershey Medical Center who have chronic in-utero opioid exposure and are at least 35 weeks gestation.
Not a fit: Patients who are less than 35 weeks gestation or have major congenital anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments and tailored treatments for infants suffering from Neonatal Opioid Withdrawal Syndrome.
How similar studies have performed: While the approach of using microRNA biomarkers in this context is innovative, similar studies have shown promise in understanding the biological mechanisms of opioid exposure in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Steven D. Hicks, MD, PhD — Associate Professor of Pediatrics
- Study coordinator: Rhea E Sullivan, B.S.
- Email: rsullivan2@pennstatehealth.psu.edu
- Phone: 717-531-0003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.