MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05937594
Study type	Observational
Source	Milton S. Hershey Medical Center
Contact	Rhea E Sullivan, B.S.
Phone	717-531-0003
Email	rsullivan2@pennstatehealth.psu.edu
Status	Recruiting
Phase
Start date	January 15, 2020
Completion date	April 10, 2025

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03890562` - Assessing the Effects of Auricular Acupressure on Newborns With NAS	N/A
Completed	`NCT01958476` - Improving Outcomes in Neonatal Abstinence Syndrome	Phase 3
Active, not recruiting	`NCT01734551` - NAS Treatment - Opiate Versus Non-Opiate	Phase 4
Completed	`NCT00496951` - Vagal Tone and Neonatal Abstinence Syndrome	N/A
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Recruiting	`NCT05226624` - The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program	N/A
Completed	`NCT03670160` - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome	Phase 2
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Completed	`NCT02182973` - Donor Human Milk in Neonatal Abstinence Syndrome