An observational study in Neonatal Abstinence Syndrome, sponsored by Rekovar Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged Up to 4 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Rekovar Inc. · 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 2nd largest by planned enrollment of the 12 observational ones that give a count, is one of 3 that started in 2024, is one of 12 observational ones, and was the 58th 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
Milton S. Hershey Medical Center · Sites in United States
Ages 1 days–5 days
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 28 wk+
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: Up to 4 Weeks · all sexes · healthy volunteers too.
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. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above 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.
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4 of 59 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Rekovar Inc. as lead sponsor.
Rekovar Inc. 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 |
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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.
Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments.
The current diagnostic and assessment framework for NAS heavily relies on subjective methods, primarily the Finnegan Neonatal Abstinence Score (FNAS). FNAS helps providers evaluate pharmacological and non-pharmacological treatments and monitor the progress of infants with NAS. The Eat Sleep Console (ESC) approach has been implemented in some hospitals to emphasize non-pharmacological interventions as the primary method of managing and treating NAS. Despite the high prevalence of NAS and the significant resources allocated to its management, the healthcare system continues to grapple with an unmet clinical need for standardized diagnostic and treatment protocols.
The reliance on subjective assessments contributes to this challenge, as FNASS and ESC introduce variability in care that can affect outcomes. Developing objective, reliable tools for assessing NAS severity and guiding treatment decisions remains a critical need in neonatal care, promising to enhance the efficiency and effectiveness of interventions for these vulnerable patients. Recent studies have underscored the lack of consistency in diagnosing and treating NAS, revealing a broad spectrum of practices across different pediatric healthcare settings. This problematic inconsistency leads to varied patient outcomes and a lack of clarity on best practices.
This multicenter study will collect data that will be used to develop an AI-based tool that can automate scoring with predictive analytics. Additionally, the investigators aim to establish the advantages of continuous monitoring in NAS that should lead to decreased length of stay in the NICU and improved patient outcomes.
NAS affected neonates and healthy neonates.
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Exclusion Criteria:
These are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages.
Other: NeoMonki
Collection of Data for assessing the reliability of Neomonki and Realtime monitoring
Training/validation data collection
Physiological data collected to be used for training and validation of AI model development in-house to help monitor and treat NAS.
Time frame: 2.5 years
Continuous Monitoring
This endpoint will be used to compare the validity of the scoring data collected continuously from the device to intermittent scoring from healthcare providers.
Time frame: 1.5 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Jun 2026, 27 months after the start.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Neonatal Abstinence Syndrome →