Neonatal Opioid Withdrawal SyndromeNCT05937594
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
An observational study of Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
- What is being tested?
- Buccal swab saliva for further genetic testing
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 10 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants enrolled into the study were exposed to opiates in-utero for at least one month of gestation. All infants enrolled meet the eligibility criteria listed above.
Who may be able to join
- Newborns ≥35weeks gestation with chronic in-utero opioid exposure (>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care
- Neonates born at Penn State Hershey Medical Center or transferred at <48 hours after birth
- Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)
Who cannot join
- <35 week gestation
- Infant required mechanical ventilation or non-invasive mechanical support
- Infant exposure to magnesium sulfate
- Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (<48hours after birth).
- Infant with major congenital anomalies
- Parent or guardian unable to provide consent
- Mothers and neonates without history of opioid exposure/dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Understanding the microRNA Response to Opioid Withdrawal and Their Uses as Potential Biomarkers for Neonatal Abstinence 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 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.
- Being tested
- Buccal swab saliva for further genetic testing
- Keywords
- microRNA, saliva, neurodevelopmental, exosomes, infant
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal swab saliva for further genetic testingGenetic
Genetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.
| Study group | Role | What they receive |
|---|---|---|
| Infants exposed to in utero opiates | Infants that meet IRB-approved inclusion/exclusion criteria. Receives: Genetic: Buccal swab saliva for further genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental outcome scores
Measured by Ages and Stages Questionnaire-3, score scale 0-60
Measured: 6 months of age
Maximum concentration of morphine required for withdrawal symptom control
Measured in mg/kg/ml
Measured: Measured during the course of hospital stay
Salivary microRNA level let-7a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Measured: Buccal swab collected within 96 hrs of life and at discharge
Salivary level of microRNA-146a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Measured: Buccal swab collected within 96 hrs of life and at discharge
Salivary level of microRNA-192
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Measured: Buccal swab collected within 96 hrs of life and at discharge
Salivary level of microRNA-149-3p
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Measured: Buccal swab collected within 96 hrs of life and at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start15 Jan 2020
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Opioid Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven Hicks, Penn State University
- Investigators
- Steven D. Hicks, MD, PhD, Principal investigator, Associate Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937594
- Sponsor's protocol ID
- 13565
- Other IDs
- F30DA057094
- Status last verified
- Jan 2026
- First submitted
- 30 Jun 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the microRNA Response to Opioid Withdrawal and Their Uses as Potential Biomarkers for Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT05937594
- Acronym / sponsor ID
- 13565
- Keywords
- microRNA, saliva, neurodevelopmental, exosomes, infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants exposed to in utero opiates | – | Genetic: Buccal swab saliva for further genetic testingInfants that meet IRB-approved inclusion/exclusion criteria. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants enrolled into the study were exposed to opiates in-utero for at least one month of gestation. All infants enrolled meet the eligibility criteria listed above.
Key inclusion criteria (3 listed)
- Newborns ≥35weeks gestation with chronic in-utero opioid exposure (>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care
- Neonates born at Penn State Hershey Medical Center or transferred at <48 hours after birth
- Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)
Key exclusion criteria (7 listed)
- <35 week gestation
- Infant required mechanical ventilation or non-invasive mechanical support
- Infant exposure to magnesium sulfate
- Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (<48hours after birth).
- Infant with major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal swab saliva for further genetic testingGenetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification. | Genetic | Infants exposed to in utero opiates |
Primary outcome
Neurodevelopmental outcome scores
Time frame: 6 months of age
Measured by Ages and Stages Questionnaire-3, score scale 0-60
Maximum concentration of morphine required for withdrawal symptom control
Time frame: Measured during the course of hospital stay
Measured in mg/kg/ml
Salivary microRNA level let-7a
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Salivary level of microRNA-146a
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Salivary level of microRNA-192
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Salivary level of microRNA-149-3p
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven D. Hicks, MD, PhD principal investigator
Associate Professor of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rhea E Sullivan, B.S. (717-531-0003 ext. 321585, rsullivan2@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental outcome scores (time frame: 6 months of age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.