MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT05937594
Status
Recruiting
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Conditions

  • Neonatal Abstinence Syndrome
  • Neonatal Opioid Withdrawal Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Day - 5 Days
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 15, 2020
Status verified
Jan 2026
Primary completion
Dec 10, 2026
Completion
Apr 10, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Infants exposed to in utero opiates
    Infants that meet IRB-approved inclusion/exclusion criteria.

Primary Outcome Measure

Neurodevelopmental outcome scores [ Time Frame: 6 months of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-

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Penn State Milton S. Hershey Medical Center· Hershey, PA

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