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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 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.

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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.

Interventions

  • GENETIC Buccal swab saliva for further genetic testing

Study Locations (1)

Pennsylvania

  • Penn State Milton S. Hershey Medical Center - Hershey

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2020-01-15
Est. Completion 2027-04-10

Sponsor

Milton S. Hershey Medical Center

396 total trials

What the Registry Record Tells You About NCT05937594

The ClinicalTrials.gov registry entry for NCT05937594 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (22% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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