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

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
Rekovar Inc.
Study ID
NCT06303986
Status
Enrolling By Invitation

Conditions

  • Neonatal Abstinence Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 4 Weeks
Healthy Volunteers
Accepted

Interventions

  • NeoMonki — OTHER
    Collection of Data for assessing the reliability of Neomonki and Realtime monitoring

Study Details

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.

Key Dates

Start date
Mar 18, 2024
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Observational Group
    These are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages.

Primary Outcome Measure

Training/validation data collection [ Time Frame: 2.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87106-

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