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

The current diagnostic and assessment framework for NAS heavily relies on subjective methods, primarily the Finnegan Neonatal Abstinence Score (FNAS). FNAS helps providers evaluate pharmacological and non-pharmacological treatments and monitor the progress of infants with NAS. The Eat Sleep Console (ESC) approach has been implemented in some hospitals to emphasize non-pharmacological interventions as the primary method of managing and treating NAS. Despite the high prevalence of NAS and the significant resources allocated to its management, the healthcare system continues to grapple with an unmet clinical need for standardized diagnostic and treatment protocols.

The reliance on subjective assessments contributes to this challenge, as FNASS and ESC introduce variability in care that can affect outcomes. Developing objective, reliable tools for assessing NAS severity and guiding treatment decisions remains a critical need in neonatal care, promising to enhance the efficiency and effectiveness of interventions for these vulnerable patients. Recent studies have underscored the lack of consistency in diagnosing and treating NAS, revealing a broad spectrum of practices across different pediatric healthcare settings. This problematic inconsistency leads to varied patient outcomes and a lack of clarity on best practices.

This multicenter study will collect data that will be used to develop an AI-based tool that can automate scoring with predictive analytics. Additionally, the investigators aim to establish the advantages of continuous monitoring in NAS that should lead to decreased length of stay in the NICU and improved patient outcomes.

Inclusion criteria

• 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 criteria

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