The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Abstract

BACKGROUND: The SafeBoosC phase II multicentre randomised clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline versus no NIRS-data and treatment as usual in the control group during the first 72 hours 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 analysed treatment effects on EEG (burst rate and spectral edge frequency 95%) and blood biomarkers of brain injury (S100β, brain-fatty-acid-binding-protein, and neuroketal). METHODS: One-hundred-and-sixty-six extremely preterm infants were randomised to either experimental or control group. EEG was recorded at 64 hours of age and blood samples were collected at 6 and 64 hours of age. RESULTS: One-hundred-and-thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 versus control 7.7 burst/min.) or spectral edge frequency 95% (experimental 18.1 versus control 18.0 Hertz). The two groups did not differ regarding blood S100β, brain-fatty-acid-binding-protein, and neuroketal concentrations at 6 and 64 hours (n=123 participants). CONCLUSIONS: Treatment guided by near-infrared spectroscopy reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.