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MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

NCT05937594 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-10

No results posted yet for this 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.

Conditions

  • Neonatal Opioid Withdrawal Syndrome
  • Neonatal Abstinence Syndrome

Interventions

GENETIC

Buccal swab saliva for further genetic testing

Genetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Steven D. Hicks, MD, PhD · Associate Professor of Pediatrics

Eligibility

Min Age
1 Day
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2026-12-10
Completion
2027-04-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937594 on ClinicalTrials.gov