MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Understanding the microRNA Response to Opioid Withdrawal and Their Uses as Potential Biomarkers for Neonatal Abstinence Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937594
• Other study ID #: 13565
• Secondary ID: F30DA057094
• Status: Recruiting
• Start date: January 15, 2020
• Est. completion date: April 10, 2025

Study information

• Verified date: July 2023
• Source: Milton S. Hershey Medical Center
• Contact: Rhea E Sullivan, B.S.
• Phone: 717-531-0003
• Email: rsullivan2[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 10, 2025
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Genetic:
• Buccal swab saliva for further genetic testing
Genetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental outcome scores	Measured by Ages and Stages Questionnaire-3, score scale 0-60	6 months of age
Primary	Maximum concentration of morphine required for withdrawal symptom control	Measured in mg/kg/ml	Measured at 24 hours of life
Primary	Salivary microRNA level let-7a	Relative fluorescence (Cq) measured by qPCR using established housekeeping gene	Buccal swab collected at 24 hrs of life and at discharge
Primary	Salivary level of microRNA-146a	Relative fluorescence (Cq) measured by qPCR using established housekeeping gene	Buccal swab collected at 24 hrs of life and at discharge
Primary	Salivary level of microRNA-192	Relative fluorescence (Cq) measured by qPCR using established housekeeping gene	Buccal swab collected at 24 hrs of life and at discharge