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Observational Group for Neonatal Abstinence Syndrome

N/A
Recruiting
Led By Nitin Chouthai, MD
Research Sponsored by Rekovar Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study 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.

Eligible Conditions
  • Neonatal Abstinence Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Training/validation data collection
Secondary outcome measures
Continuous Monitoring

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational GroupExperimental Treatment1 Intervention
These are the neonates enrolled in the study to collect data and aid in establishing continuous monitoring advantages.

Find a Location

Who is running the clinical trial?

Children's Hospital of Orange CountyOTHER
32 Previous Clinical Trials
4,874 Total Patients Enrolled
Rekovar Inc.Lead Sponsor
Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,593 Total Patients Enrolled
6 Trials studying Neonatal Abstinence Syndrome
412 Patients Enrolled for Neonatal Abstinence Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~40 spots leftby Jun 2024