MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorMilton S. Hershey Medical Center

About this trial

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

Qualifiers

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)

Disqualifiers

<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).

Trial design

Treatments tested in this trial

  • Buccal swab saliva for further genetic testing

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Milton S. Hershey Medical Center

Lead sponsor

Penn State University

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator