Derivation of Novel Imaging Biomarkers of Neonatal Brain Injury Using Bedside Diffuse Optical Tomography: Protocol for a Prospective Feasibility Study

TL;DR

This study tests the feasibility of using bedside DOT imaging to derive new biomarkers for predicting brain injury outcomes in neonates with HIE.

Contribution

The study introduces a feasibility protocol for using DOT to assess neonatal brain function and improve prognostication of HIE.

Findings

The study will recruit 25 neonates with HIE and follow them for 12 months to assess DOT-based biomarkers.

A customized neonatal cap and MATLAB-based software will be used to measure cortical functional connectivity.

Feasibility results will inform the design of a larger study on DOT's clinical utility in neonatal brain injury.

Abstract

Prognostication of neurodevelopmental outcomes for neonates with hypoxic–ischemic encephalopathy (HIE) is primarily reliant on structural assessment using conventional brain magnetic resonance imaging in the clinical setting. Diffuse optical tomography (DOT) can provide complementary information on brain function at the bedside, further enhancing prognostic accuracy. The predictive accuracy and generalizability of DOT-based neuroimaging markers are unknown. This study aims to test the feasibility of prospectively recruiting and retaining neonates for 12 months in a larger study that investigates the prognostic utility of DOT-based biomarkers of HIE. The study will recruit 25 neonates with HIE over one year and follow them beyond NICU discharge at 6 and 12 months of age. Study subjects will undergo resting-state DOT measurement within 7 days of life for a 30–45-min period without sedation. A customized neonatal cap with 10 sources and eight detectors per side will be used to quantify cortical functional connectivity and to generate brain networks using MATLAB-based software (version 24.2). The Ages and Stages Questionnaires—3rd edition will be used for standardized developmental assessments at follow-up. This feasibility study will help refine the design and sample-size calculation for an adequately powered larger study that determines the clinical utility of DOT-based neuroimaging in perinatal brain injury.

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