Pows for nows: using physiomarkers as an objective tool for assessing the withdrawing infant

Ended Project Grant Awarded Last action

Award ID
R18EB035019
Recipient
Awarding agency
Obligated
$0

Award facts

Completion date
Place of performance
Virginia, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Neonatal opioid withdrawal syndrome (nows) is a complex disorder with variable presentation and severity. The current gold standard for evaluation and treatment uses subjective evaluation and provision of non- pharmacologic and pharmacologic treatments. Challenges in inter-observer assessment variability and overlap with normal neonatal behavior leads to substantial ambiguity and variation in care, contributing to delays in treatment and discharge. Neonatal withdrawal is expressed predominantly through autonomic hyperexcitability, which can be detected through quantitative analysis of non-invasive heart rate (HR) and oxygenation (SPO2). A critical GAP exists in the objective assessment of nows; no current device or test can provide a quantitative monitoring or prediction of withdrawal symptoms. Closing this GAP using an objective algorithm would pay enormous dividends in both the newborn nursery and the neonatal ICU. Preliminary results indicate that signatures of nows can be detected using continuous pulse oximetry data analytics and these correlate with clinical markers of withdrawal severity. Translating features of nows in pulse oximetry data into a real-time objective measure of withdrawal would provide an actionable tool for providers and directly address the primary GAP in the care of these vulnerable infants. In this project, we will use data from term infants to refine and validate a pulse oximetry withdrawal score (pows) for nows symptom monitoring and assessment. In an existing commercial partnership, we will develop and test a device prototype in a prospective feasibility study. To inform product design and engineering, we will compile input from key stakeholders, including parents, providers, and regulatory bodies. Upon completion, the project will yield a device ready for a clinical trial.

Transactions

Action Obligated Date
Amendment -$3,149,700
Original award $3,149,700

Subawards

Subrecipient Amount Awarded
University Of Alabama At Birmingham For Aim 1, we will identify infants for the retrospective database and modeling according to the approved inclusion andexclusion criteria. The work will involve… $673,250
Medical Predictive Science Corp For Aim 1, we work with researchers at UVA, Washington University, and UAB to understand the methods used to analyze pulse oximetry data, optimize and… $705,650
The Washington University Phase I: The work in this phase will involve extraction of retrospective bedside physiologic data from patients who have been admitted to the NICU at St.… $682,145

Quick answers

Who received award R18EB035019?

R18EB035019 was awarded to Rector & Visitors Of The University Of Virginia by National Institute of Biomedical Imaging and Bioenginering (National Institutes of Health) on August 1, 2023.

How much is award R18EB035019 worth?

$0 has been obligated on R18EB035019.

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