MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Last updated: January 8, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Buccal swab saliva for further genetic testing

Clinical Study ID

NCT05937594
13565
F30DA057094
  • Ages 1-5
  • All Genders

Study 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

Inclusion Criteria:

  • Newborns ≥35weeks gestation with chronic in-utero opioid exposure (>1month ofgestation exposure). Maternal exposure will be determined by evaluating the medicalrecords for maternal medication use, maternal urine toxicology and neonatal meconiumtoxicology results per standard clinical care

  • Neonates born at Penn State Hershey Medical Center or transferred at <48 hours afterbirth

  • Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)

Exclusion

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 persistentneonatal 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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Buccal swab saliva for further genetic testing
Phase:
Study Start date:
January 15, 2020
Estimated Completion Date:
April 10, 2026

Connect with a study center

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

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