MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

NCT05937594 | Recruiting

• 2 other identifiers: 13565F30DA057094
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

microRNA; saliva; neurodevelopmental; exosomes; infant

Outcome Measures

Primary Outcomes (6)

• Neurodevelopmental outcome scores

  Measured by Ages and Stages Questionnaire-3, score scale 0-60

  6 months of age

• Maximum concentration of morphine required for withdrawal symptom control

  Measured in mg/kg/ml

  Measured during the course of hospital stay

• Salivary microRNA level let-7a

  Relative fluorescence (Cq) measured by qPCR using established housekeeping gene

  Buccal swab collected within 96 hrs of life and at discharge

• Salivary level of microRNA-146a

  Relative fluorescence (Cq) measured by qPCR using established housekeeping gene

  Buccal swab collected within 96 hrs of life and at discharge

• Salivary level of microRNA-192

  Relative fluorescence (Cq) measured by qPCR using established housekeeping gene

  Buccal swab collected within 96 hrs of life and at discharge

• Salivary level of microRNA-149-3p

  Relative fluorescence (Cq) measured by qPCR using established housekeeping gene

  Buccal swab collected within 96 hrs of life and at discharge

Study Arms (1)

Infants exposed to in utero opiates

Infants that meet IRB-approved inclusion/exclusion criteria.

Genetic: Buccal swab saliva for further genetic testing

Interventions

Buccal swab saliva for further genetic testing GENETIC

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

Infants exposed to in utero opiates

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants enrolled into the study were exposed to opiates in-utero for at least one month of gestation. All infants enrolled meet the eligibility criteria listed above.

You may qualify if:

• 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)

You may not qualify if:

• \<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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva swab samples are collected from infants. Saliva samples are immediately stored at -80 for later nucleic acid extraction.

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Steven D. Hicks, MD, PhD

  Associate Professor of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rhea E Sullivan, B.S.

CONTACT

717-531-0003; rsullivan2@pennstatehealth.psu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: January 15, 2020
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): April 10, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)