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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05937594
Study type Observational
Source Milton S. Hershey Medical Center
Contact Rhea E Sullivan, B.S.
Phone 717-531-0003
Email rsullivan2@pennstatehealth.psu.edu
Status Recruiting
Phase
Start date January 15, 2020
Completion date April 10, 2025

See also
  Status Clinical Trial Phase
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Completed NCT03890562 - Assessing the Effects of Auricular Acupressure on Newborns With NAS N/A
Completed NCT01958476 - Improving Outcomes in Neonatal Abstinence Syndrome Phase 3
Active, not recruiting NCT01734551 - NAS Treatment - Opiate Versus Non-Opiate Phase 4
Completed NCT00496951 - Vagal Tone and Neonatal Abstinence Syndrome N/A
Completed NCT02851303 - Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome Phase 4
Recruiting NCT05226624 - The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program N/A
Completed NCT03670160 - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome Phase 2
Not yet recruiting NCT04611659 - Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine N/A
Completed NCT01452789 - Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome Phase 3
Completed NCT04588519 - tAN to Mitigate Withdrawal Behaviors in Neonates N/A
Completed NCT02797990 - Conflict Between Maternal Autonomy and Child Health in Substance-use N/A
Completed NCT02801331 - Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome N/A
Terminated NCT03246243 - Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
Completed NCT03567603 - Sound Processing Changes in Babies With Opioid Exposure
Recruiting NCT06303986 - Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Active, not recruiting NCT03725332 - The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky N/A
Recruiting NCT04983563 - Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units N/A
Completed NCT04298853 - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Phase 4
Completed NCT02182973 - Donor Human Milk in Neonatal Abstinence Syndrome