- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303986
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
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
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Neema Onbirbak, BS
- Phone Number: 9493741604
- Email: neema.onbirbak@rekovar.com
Study Contact Backup
- Name: Shiva Sharareh, PhD
- Phone Number: 9498781023
- Email: shiva.sharareh@rekovar.com
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Recruiting
- John Hopkins University
-
Contact:
- Krystle McConnell, MPH
- Phone Number: 410-550-8779
- Email: kgreen39@jhmi.edu
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Principal Investigator:
- Lauren Jansson, MD
-
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Recruiting
- University of New Mexico
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Contact:
- Sandra S Beauman, MSN, RNC-NIC
- Phone Number: 505-272-0363
- Email: sbeauman@salud.unm.edu
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Principal Investigator:
- Jessie R Maxwell, MD, MBA
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The investigators are NOT purposefully excluding or including any gender or race in our studies.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational Group
These are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages.
|
The Neomonki is a monitoring kit for hospital use in neonates with Neonatal Abstinence Syndrome (NAS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training/validation data collection
Time Frame: 1.5 years
|
Physiological data collected to be used for training and validation of AI model development in-house to help monitor and treat NAS.
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous Monitoring
Time Frame: 1.5 years
|
This endpoint will be used to compare the validity of the scoring data collected continuously from the device to intermittent scoring from healthcare providers.
|
1.5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nitin Chouthai, MD, Rekovar Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAS-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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