RECRUITING

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-01-15
Study Completion:2025-04-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05937594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 5 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Neonates born at Penn State Hershey Medical Center or transferred at \<48 hours after birth
  3. * Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)
  1. * \<35 week gestation
  2. * Infant required mechanical ventilation or non-invasive mechanical support
  3. * Infant exposure to magnesium sulfate
  4. * Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (\<48hours after birth).
  5. * Infant with major congenital anomalies
  6. * Parent or guardian unable to provide consent
  7. * Mothers and neonates without history of opioid exposure/dependence

Contacts and Locations

Study Contact

Rhea E Sullivan, B.S.
CONTACT
717-531-0003
rsullivan2@pennstatehealth.psu.edu

Principal Investigator

Steven D. Hicks, MD, PhD
PRINCIPAL_INVESTIGATOR
Associate Professor of Pediatrics

Study Locations (Sites)

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-15
Study Completion Date2025-04-10

Study Record Updates

Study Start Date2020-01-15
Study Completion Date2025-04-10

Terms related to this study

Keywords Provided by Researchers

  • microRNA
  • saliva
  • neurodevelopmental
  • exosomes
  • infant

Additional Relevant MeSH Terms

  • Neonatal Opioid Withdrawal Syndrome
  • Neonatal Abstinence Syndrome