MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

NCT ID: NCT05937594

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2027-04-10

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infants exposed to in utero opiates

Infants that meet IRB-approved inclusion/exclusion criteria.

Buccal swab saliva for further genetic testing

Intervention Type: GENETIC

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

Interventions

Buccal swab saliva for further genetic testing

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

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 5 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Hicks

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven D. Hicks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Pediatrics

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rhea E Sullivan, B.S.

Role: CONTACT

rsullivan2@pennstatehealth.psu.edu

717-531-0003 ext. 321585

Other Identifiers

F30DA057094

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13565

Identifier Type: -

Identifier Source: org_study_id