Identifying microRNA biomarkers for infants with opioid withdrawal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.