Recruiting

MicroRNA Biomarkers

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT05937594

Conditions

Neonatal Opioid Withdrawal Syndrome

Neonatal Abstinence Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Buccal swab saliva for further genetic testing

Study Details

Brief summary:

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.

Conditions

Neonatal Opioid Withdrawal Syndrome

Neonatal Abstinence Syndrome

Study ID

NCT05937594

Start date

Jan 15, 2020

Status verified date

Jan, 2026

Completion date

Apr 10, 2027

Anticipated

Primary completion date

Dec 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants exposed to in utero opiates

Infants that meet IRB-approved inclusion/exclusion criteria.

Interventions

Buccal swab saliva for further genetic testing

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rhea E Sullivan, B.S.

717-531-0003rsullivan2@pennstatehealth.psu.edu

Locations

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Feb 10, 2026

Last verified

Jan, 2026

Keywords

  • microRNA
  • saliva
  • neurodevelopmental
  • exosomes
  • infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-02-10.