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The SafeBoosC II randomized trial |
The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury
Carlos F Muniz, Apeksha V Shenoy, Kathryn L OʼConnor, Sophia C Bechek, Emily J Boyle, Mary M Guanci, Tara M Tehan, Sahar F Zafar, Andrew J Cole, Aman B Patel, Michael B Westover, Eric S Rosenthal
Abstract
Background: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95)) and blood biomarkers of brain injury (S100β, brain fatty acid-binding protein, and neuroketal).