MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Penn State Health

Status

Enrolling

Conditions

Neonatal Abstinence Syndrome

Neonatal Opioid Withdrawal Syndrome

Treatments

Genetic: Buccal swab saliva for further genetic testing

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05937594

13565

F30DA057094 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment

50 estimated patients

Sex

All

Ages

1 to 5 days old

Volunteers

No Healthy Volunteers

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