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NCT06303986

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

Enrolling by Invitation
Not specifiedUp to 4Observational
Rekovar Inc.
~100 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:NeoMonki

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Training/validation data collection
Measured over 2.5 years

Conditions

Neonatal Abstinence Syndrome

Explore related trials

Neonatal Abstinence Syndrome

Where it's being run

1 sites across 1 states
New Mexico1

Study leadership

  • Nitin Chouthai, MD · PRINCIPAL_INVESTIGATOR · Rekovar Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Training/validation data collection2.5 years

    Physiological data collected to be used for training and validation of AI model development in-house to help monitor and treat NAS.