NeoMonki for Neonatal Abstinence Syndrome

Enrolling by invitation at 1 trial location

Overseen By Shiva Sharareh, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rekovar Inc.

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather data to develop an AI tool that can predict and monitor symptoms of Neonatal Abstinence Syndrome (NAS). The goal is to improve NAS assessment in newborns, allowing for more precise treatment guidance. The trial seeks participation from newborns affected by NAS and healthy newborns. This opportunity may suit those whose newborns have been diagnosed with NAS or exposed to opioids during pregnancy. As an unphased trial, this study offers a unique chance to contribute to groundbreaking research that could enhance future care for newborns with NAS.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this method is safe for neonatal abstinence syndrome?

Research shows that NeoMonki, the system being tested for helping newborns with Neonatal Abstinence Syndrome (NAS), has received approval from the Western Institutional Review Board (WIRB). This approval indicates that experts consider the system safe to use. NeoMonki is designed to closely monitor newborns with NAS. Monitoring patients is known to help them recover faster and reduce hospital stays. No reports of problems with NeoMonki have emerged in the available information. The approval and focus on data collection suggest the system is safe for babies. As a monitoring system rather than a medication, NeoMonki carries fewer risks of side effects or drug interactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance how we monitor and manage Neonatal Abstinence Syndrome (NAS) using an automated data collection process. Unlike traditional methods that rely on periodic manual assessments, this new approach could offer continuous monitoring, providing real-time insights into a newborn's condition. This could lead to more timely and precise interventions, potentially improving outcomes for affected infants.

What evidence suggests that the NeoMonki device is effective for Neonatal Abstinence Syndrome?

Studies have shown that closely monitoring vital signs can help newborns recover faster and reduce hospital stays. In this trial, NeoMonki employs advanced technology to analyze data from sensors, predicting signs of Neonatal Abstinence Syndrome (NAS). This technology provides healthcare providers with real-time, accurate information. Early research suggests it could lead to more personalized and effective treatments for newborns with NAS. The goal is to shorten the time babies spend in the Neonatal Intensive Care Unit (NICU) and enhance their overall care. ^{1 2 6 7 8}

Who Is on the Research Team?

Nitin Chouthai, MD

Principal Investigator

Rekovar Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

My newborn is affected by neonatal abstinence syndrome.

I am a ward of the court and can join the study with an advocate's approval and proper consent.

My newborn has been diagnosed with NAS or exposed to opioids/drugs causing NAS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Physiological and behavioral data of NAS patients are collected to develop an AI algorithm and establish the advantages of continuous monitoring

1.5 years

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NeoMonki

How Is the Trial Designed?

Group I: Observational Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Rekovar Inc.

Lead Sponsor

Trials

1

Recruited

60+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

Corewell Health East Dearborn Hospital and Royal Oak Hospital

Collaborator

Children's Hospital of Orange County

Collaborator

Trials

38

Recruited

5,700+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/11065556

Project Details - NIH RePORTER

Neomonki will revolutionize neonatal healthcare with a cutting- edge AI clinical algorithm that analyzes biosensor and imaging data to deliver predictive NAS ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06303986

Study to Collect Data for Neonatal Abstinence Syndrome ...

Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning ...

3.

reporter.nih.gov

reporter.nih.gov/search/DSvtOjSUDkGqTPYpit3gCg/project-details/11039621

Project Details - NIH RePORTER

Neomonki will revolutionize neonatal healthcare with a cutting-edge AI (Artificial Intelligence) clinical algorithm that analyzes biosensor and imaging data to ...

4.

alpaca-star-mers.squarespace.com

alpaca-star-mers.squarespace.com/news/rekovar-secures-multicenter-central-irb-approval-for-next-generation-nas-monitoring-system

Rekovar Secures Multicenter Central IRB Approval for Next ...

By providing healthcare professionals with accurate, real-time data, the NeoMonki system will enable more personalized and effective treatment ...

5.

hca.wa.gov

hca.wa.gov/assets/program/neonatal-abstinence-syndrome-leg-report-2024.pdf

Research and analysis of Neonatal Abstinence Syndrome

In this report, we use the term NAS due to recent data and evidence suggesting newborns are most commonly exposed to multiple substances in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11344983/

4 Council of State and Territorial Epidemiologists ...

Neonatal abstinence syndrome (NAS) is a constellation of symptoms that an infant can experience following birth after in utero exposure to some ...

7.

rekovar.com

rekovar.com/news

News

... NeoMonki Neonatal Monitoring Kit. This certification highlights our ... withdrawal detection and monitoring system for neonatal abstinence syndrome (NAS).

8.

linkedin.com

linkedin.com/posts/shiva-sharareh-phd-a1a67b4_neonatal-abstinence-syndrome-nas-continues-activity-7315877545680203776-vyd7

Neonatal abstinence syndrome (NAS) continues to be a ...

Neonatal abstinence syndrome (NAS) continues to be a significant global health concern, especially as substance misuse among pregnant women rises.