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NCT05937594 · ClinicalTrials.gov registry record
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
A clinical trial of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT05937594: Recruiting study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Milton S. Hershey Medical Center.
NCT05937594 is a study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 50 participants, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05937594, a study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured by Ages and Stages Questionnaire-3, score scale 0-60
Conditions Studied
Interventions
- GENETIC Buccal swab saliva for further genetic testing
Study Locations (1)
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2027-04-10 |
What NCT05937594 shows while recruiting
NCT05937594 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Buccal swab saliva for further genetic testing is the first listed.
NCT05937594 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05937594 about?
NCT05937594 is a clinical study titled "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 m...
What is the current status of trial NCT05937594?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2020-01-15. Estimated completion is 2027-04-10.
What conditions does trial NCT05937594 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome.
What interventions are being tested in trial NCT05937594?
The interventions under investigation include: Buccal swab saliva for further genetic testing (GENETIC).
Who is sponsoring clinical trial NCT05937594?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05937594 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05937594's enrollment target sits among peer trials
50 11th of 17 higher than 6 of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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-
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