An observational study in Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, sponsored by Milton S. Hershey Medical Center. Recruiting at 1 site in United States. Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Milton S. Hershey Medical Center · Observational
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.
Infants enrolled into the study were exposed to opiates in-utero for at least one month of gestation. All infants enrolled meet the eligibility criteria listed above.
Exclusion Criteria:
Infants that meet IRB-approved inclusion/exclusion criteria.
Genetic: Buccal swab saliva for further genetic testing
Genetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.
Neurodevelopmental outcome scores
Measured by Ages and Stages Questionnaire-3, score scale 0-60
Time frame: 6 months of age
Maximum concentration of morphine required for withdrawal symptom control
Measured in mg/kg/ml
Time frame: Measured during the course of hospital stay
Salivary microRNA level let-7a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Salivary level of microRNA-146a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Salivary level of microRNA-192
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Salivary level of microRNA-149-3p
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Plan to share: No
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Milton S. Hershey Medical Center