Neonatal Abstinence SyndromeNCT06303986
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
An observational study of Neonatal Abstinence Syndrome, run by Rekovar Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- NeoMonki
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 30 Jun 2026
- How long will I take part?
- 1 Week
- 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 Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: NAS affected neonates and healthy neonates.
Who may be able to join
- The subject selection criteria per site will be 80% term neonates affected by neonatal abstinence syndrome (NAS) and 20% term neonates without any health complications.
- The eligible screening process for the NAS neonates in the study will include neonates affected by NAS, newborn infants diagnosed with NAS, infants with confirmed history of prenatal exposure to opioids or other drugs that can cause NAS, and infants who meet specific diagnostic criteria for NAS based on standardized clinical assessments.
- The eligible screening process for neonates without any health complications include newborn infants without any known health complications or medical conditions, infants with a normal physical examination and absence of clinical signs or symptoms suggestive of NAS or other health issues.
- Given the simple nature of the study, wards of the courts will also be enrolled upon evaluating the appropriateness, identifying an advocate if required, and providing an approved consent for the ward subject.
Who cannot join
- The investigators are NOT purposefully excluding or including any gender or race in our studies.
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
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: A Multi-center Study to Collect Data for Basic Physiological Research in Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Finnegan/ESC Data Collection Process
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.
Read the detailed description
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.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- NeoMonki
- 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.
NeoMonkiOther
Collection of Data for assessing the reliability of Neomonki and Realtime monitoring
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | These are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages. Receives: Other: NeoMonki |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5 years
Secondary outcomes (1)
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start18 Mar 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Rekovar Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico, The University of Texas Health Science Center at San Antonio, Corewell Health East Dearborn Hospital and Royal Oak Hospital
- Responsible party
- Sponsor
- Investigators
- Nitin Chouthai, MD, Principal investigator, Rekovar Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303986
- Sponsor's protocol ID
- NAS-002
- Status last verified
- Aug 2025
- First submitted
- 26 Feb 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study to Collect Data for Basic Physiological Research in Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Finnegan/ESC Data Collection Process
- ClinicalTrials.gov ID
- NCT06303986
- Acronym / sponsor ID
- NAS-002
- Conditions
- Neonatal Abstinence Syndrome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rekovar Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico, The University of Texas Health Science Center at San Antonio, Corewell Health East Dearborn Hospital and Royal Oak Hospital
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Other: NeoMonkiThese are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- NAS affected neonates and healthy neonates.
Key inclusion criteria (4 listed)
- The subject selection criteria per site will be 80% term neonates affected by neonatal abstinence syndrome (NAS) and 20% term neonates without any health complications.
- The eligible screening process for the NAS neonates in the study will include neonates affected by NAS, newborn infants diagnosed with NAS, infants with confirmed history of prenatal exposure to opioids or other drugs that can cause NAS, and infants who meet specific diagnostic criteria for NAS based on standardized clinical assessments.
- The eligible screening process for neonates without any health complications include newborn infants without any known health complications or medical conditions, infants with a normal physical examination and absence of clinical signs or symptoms suggestive of NAS or other health issues.
- Given the simple nature of the study, wards of the courts will also be enrolled upon evaluating the appropriateness, identifying an advocate if required, and providing an approved consent for the ward subject.
Key exclusion criteria (1 listed)
- The investigators are NOT purposefully excluding or including any gender or race in our studies.
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 |
|---|---|---|
| NeoMonkiCollection of Data for assessing the reliability of Neomonki and Realtime monitoring | Other | Observational Group |
Primary outcome
Training/validation data collection
Time frame: 2.5 years
Physiological data collected to be used for training and validation of AI model development in-house to help monitor and treat NAS.
1 secondary outcome
Continuous Monitoring
Time frame: 1.5 years
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 9 Sep 2025.
- Rekovar IncLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Neonatal Abstinence Syndrome
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
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.
Nitin Chouthai, MD principal investigator
Rekovar Inc.
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 Abstinence Syndrome, run by Rekovar Inc. 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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training/validation data collection (time frame: 2.5 years). 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 9 Sep 2025.