An observational study in Neonatal Opioid Withdrawal Syndrome and Neonatal Abstinence Syndrome, sponsored by Milton S. Hershey Medical Center. Recruiting at 1 site in United States. Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Milton S. Hershey Medical Center · Observational
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Among 59 studies in Neonatal Abstinence Syndrome with a site in United States — 4 open to participants now, 7 under way, none of them phase 3. Neonatal Abstinence Syndrome · United States.
Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, this one is the 7th largest by planned enrollment of the 12 observational ones that give a count, is one of 9 that started in 2020, is one of 12 observational ones, and was the 57th registered.
68 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
Browse Neonatal Abstinence Syndrome studies →4 of the 59 studies in Neonatal Abstinence Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 28 wk+
Rekovar Inc. · Sites in United States
Ages up to 4 wk · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Neonatal Abstinence Syndrome studies recruiting now, 3 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 1 Day to 5 Days · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 12 · Phase 3 10 · Phase 4 6
First in 2002; this study’s year is marked. 9 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 50 across 15 observational studies indexed under Neonatal Abstinence Syndrome.
Median enrollment 42 across the 47 interventional studies, 58 across the 12 observational. Of the 50 that completed or were terminated, 26 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 59 have an industry lead sponsor. The 10 most frequent:
Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
Milton S. Hershey Medical Center has 1 study filed under Neonatal Abstinence Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Neonatal Abstinence Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05937594Milton S. Hershey Medical CenterMicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome | 2026-12-10 |
| NCT03533985Icahn School of Medicine at Mount SinaiEffect of Music Therapy on Infants With Neonatal Abstinence Syndrome | 2026-12-31 |
| NCT06576323University of PennsylvaniaAn Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT) | 2027-05-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Infants that meet IRB-approved inclusion/exclusion criteria.
Genetic: Buccal swab saliva for further genetic testing
Genetic testing. Whole saliva RNA will be isolated for downstream microRNA quantification.
Neurodevelopmental outcome scores
Measured by Ages and Stages Questionnaire-3, score scale 0-60
Time frame: 6 months of age
Maximum concentration of morphine required for withdrawal symptom control
Measured in mg/kg/ml
Time frame: Measured during the course of hospital stay
Salivary microRNA level let-7a
Relative fluorescence (Cq) measured by qPCR using established housekeeping gene
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Buccal swab collected within 96 hrs of life and at discharge
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Dec 2026, 82 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Neonatal Abstinence Syndrome →
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