Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process

NCT06303986 | Enrolling By Invitation DMC

• 1 other identifier: NAS-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  2.5 years

Secondary Outcomes (1)

• Continuous Monitoring

  1.5 years

Study Arms (1)

Observational Group

These are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages.

Other: NeoMonki

Interventions

NeoMonki OTHER

Collection of Data for assessing the reliability of Neomonki and Realtime monitoring

Observational Group

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

NAS affected neonates and healthy neonates.

You may qualify if:

• 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.

You may not qualify if:

• The investigators are NOT purposefully excluding or including any gender or race in our studies.

Sponsors & Collaborators

• Rekovar Inc.: lead
• University of New Mexico: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• Corewell Health East Dearborn Hospital and Royal Oak Hospital: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Related Links

• Rekovar Inc

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nitin Chouthai, MD

  Rekovar Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: March 18, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)