Lexington, KYNCT07278375Now EnrollingIRB Ready

Neonatal Opioid Withdrawal Syndrome Clinical Trial in Lexington, KY

Access cutting-edge neonatal opioid withdrawal syndrome treatment through this clinical trial at a research site in Lexington. Study-provided care at no cost to qualified participants.

Sponsored by HELP for NOWS Consortium

Quick Self-Assessment

See if you qualify for this Lexington location

Preparing your pre-screening questions…

Expert Care in Lexington

Access neonatal opioid withdrawal syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related neonatal opioid withdrawal syndrome treatment provided free

Apply for This Lexington Location

Check if you qualify for this neonatal opioid withdrawal syndrome clinical trial in Lexington, KY

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Lexington

    Convenient for KY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lexington site if eligible
  4. 4Begin participation

About This Neonatal Opioid Withdrawal Syndrome Study in Lexington

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are: 1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other? Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly. Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care. No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.

Sponsor: HELP for NOWS Consortium

Who Can Participate

Inclusion Criteria

Infant is ≥ 36 weeks' gestational age
Infant had antenatal opioid exposure identified by at least one of the following:
History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record;
Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
Positive infant toxicology screen for opioids during the initial hospital stay.
The infant is being assessed and managed for NOWS at an eligible study site.
The infant is at risk for pharmacologic treatment for NOWS defined by either of the following:
At least 1 score ≥ 8 if assessed and managed with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or modification thereof
At least 1 "yes" if assessed and managed with the Eat, Sleep, Console (ESC) care approach
Infant met all inclusion criteria on or after March 25, 2024.

Exclusion Criteria

Infant has major congenital anomalies.
Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
Infant has undergone major surgical intervention prior to or at 48 hours of age.
Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lexington?

Yes, this clinical trial (NCT07278375) has an active research site in Lexington, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neonatal Opioid Withdrawal Syndrome Treatment Options in Lexington, KY

If you're searching for neonatal opioid withdrawal syndrome treatment options in Lexington, KY, this clinical trial (NCT07278375) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lexington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neonatal opioid withdrawal syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neonatal opioid withdrawal syndrome clinical trials near you to find additional studies recruiting in your area.

More Huntingtons Disease Trials in Lexington, KY

See all huntingtons disease clinical trials recruiting in Lexington — not just this study.

Browse Huntingtons Disease Trials in Lexington

Ready to Join in Lexington?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Lexington, KY