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Genetic Testing for Neonatal Abstinence Syndrome

N/A

Recruiting

Led By Steven D. Hicks, MD, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months of age

Awards & highlights

Study Summary

This trial will study how opioid withdrawal affects brain development in infants with neonatal abstinence syndrome to better understand & improve care.

Who is the study for?

This trial is for newborns born at or transferred to Penn State Hershey Medical Center within 48 hours of birth, who are over 35 weeks gestation and have been exposed to opioids in-utero for more than a month. Their mothers must have documented opioid use during pregnancy. Babies needing intensive respiratory support or with major congenital anomalies can't participate.Check my eligibility

What is being tested?

The study is testing if certain microRNAs in the saliva (let-7a, miR-146a, miR-192) can predict treatment needs and outcomes for babies with Neonatal Opioid Withdrawal Syndrome by using a simple buccal swab test.See study design

What are the potential side effects?

Since this trial involves collecting saliva through a buccal swab, there are minimal risks involved. The procedure is non-invasive and generally considered safe without significant side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum concentration of morphine required for withdrawal symptom control

Neurodevelopmental outcome scores

Salivary level of microRNA-146a

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Infants exposed to in utero opiatesExperimental Treatment1 Intervention

Infants that meet IRB-approved inclusion/exclusion criteria.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,824 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,681 Total Patients Enrolled

3 Trials studying Neonatal Opioid Withdrawal Syndrome

325 Patients Enrolled for Neonatal Opioid Withdrawal Syndrome

Steven D. Hicks, MD, PhDPrincipal InvestigatorAssociate Professor of Pediatrics

Media Library

Neonatal Opioid Withdrawal Syndrome Research Study Groups: Infants exposed to in utero opiates

Neonatal Opioid Withdrawal Syndrome Clinical Trial 2023: Infants exposed to in utero opiates Highlights & Side Effects. Trial Name: NCT05937594 — N/A

Infants exposed to in utero opiates 2023 Treatment Timeline for Medical Study. Trial Name: NCT05937594 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental protocol recruiting participants who are over thirty-five years old?

"Eligible participants for this trial are infants aged 1 Day to 5 Days old."

Answered by AI

Who is eligible to be part of this research initiative?

"Neonates with neonatal abstinence syndrome between 1 Day and 5 Days of age qualify for this trial, which is accepting a maximum of 50 people."

Answered by AI

Are enrollees currently being accepted into this medical experiment?

"Clinicaltrials.gov confirms that this clinical trial is still actively searching for participants, having been initially posted on January 15th 2020 and last amended on June 30th 2023."

Answered by AI

How many individuals are currently enrolled in this experiment?

"Confirmed. Clinicaltrials.gov records that this clinical trial, which was initially launched on January 15th 2020, is actively seeking volunteers. The researchers are trying to enlist 50 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome

Steven Hicks 2020. "MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05937594.