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Recruiting NCT05937594

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

— Observational Neonatal Opioid Withdrawal Syndrome Neonatal Abstinence Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buccal swab saliva for further genetic testing.
Who it may be relevant to
Registry conditions: Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome. Basic parameters: 1 Day — 5 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Neurodevelopmental outcome scores [Time frame: 6 months of age]
  • Maximum concentration of morphine required for withdrawal symptom control [Time frame: Measured during the course of hospital stay]
  • Salivary microRNA level let-7a [Time frame: Buccal swab collected within 96 hrs of life and at discharge]
  • Salivary level of microRNA-146a [Time frame: Buccal swab collected within 96 hrs of life and at discharge]
  • Salivary level of microRNA-192 [Time frame: Buccal swab collected within 96 hrs of life and at discharge]
  • Salivary level of microRNA-149-3p [Time frame: Buccal swab collected within 96 hrs of life and at discharge]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Penn State Milton S. Hershey Medical Center — Hershey

Identifiers

NCT: NCT05937594 · 13565 · F30DA057094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗