Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06303986 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 9, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Phase: Not applicable to Not specifiedv5 Show 5 more changesShow less
    • Enrollment target: 60 to 100
    • Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026
    • Study sites: 2 to 1
    • Interventions: Neomonki (Device) to NeoMonki (Other)
    • Collaborators: 4 to 3
  2. Notable Primary and study completion dates: Jun 30, 2024 to Jun 30, 2025v4
  3. Notable Phase: Not specified to Not applicable
    • Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 2 of 2 sites
    v3
  4. Notable Enrollment target: 200 to 60
    • Primary completion date: Feb 28, 2025 to Jun 30, 2024
    • Study completion date: Jul 2025 to Jun 30, 2024
    • Start date changed from estimate of Mar 1, 2024 to Mar 18, 2024
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06303986
Lead Sponsor Rekovar Inc.
Collaborators: University of New Mexico, The University of Texas Health Science Center at San Antonio, Corewell Health East Dearborn Hospital and Royal Oak Hospital
Conditions
(from sponsor)
Neonatal Abstinence Syndrome
Related terms Neonatal Abstinence Syndrome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov