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NCT Number: NCT05937594

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

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.

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Key information

Conditions

Neonatal Opioid Withdrawal Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Neonatal Abstinence Syndrome Substance-Related Disorders

Age range

1 day–5 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buccal swab saliva for further genetic testing

Genetic

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

Primary outcomes

  1. Neurodevelopmental outcome scores

    Time frame: 6 months of age

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

  2. Maximum concentration of morphine required for withdrawal symptom control

    Time frame: Measured during the course of hospital stay

    Measured in mg/kg/ml

  3. Salivary microRNA level let-7a

    Time frame: Buccal swab collected within 96 hrs of life and at discharge

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

  4. Salivary level of microRNA-146a

    Time frame: Buccal swab collected within 96 hrs of life and at discharge

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

  5. Salivary level of microRNA-192

    Time frame: Buccal swab collected within 96 hrs of life and at discharge

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

  6. Salivary level of microRNA-149-3p

    Time frame: Buccal swab collected within 96 hrs of life and at discharge

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rhea E Sullivan, B.S.

CONTACT

[email protected]

717-531-0003 ext. 321585

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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