SafeBoosC II随机试验：近红外光谱引导的治疗可减少脑缺氧，且不改变脑损伤的早期生物标志物。
The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury.
作者信息
Plomgaard Anne M, van Oeveren Wim, Petersen Tue H, Alderliesten Thomas, Austin Topun, van Bel Frank, Benders Manon, Claris Olivier, Dempsey Eugene, Franz Axel, Fumagalli Monica, Gluud Christian, Hagmann Cornelia, Hyttel-Sorensen Simon, Lemmers Petra, Pellicer Adelina, Pichler Gerhard, Winkel Per, Greisen Gorm
机构信息
Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
HaemoScan B.V., Groningen, The Netherlands.
出版信息
Pediatr Res. 2016 Apr;79(4):528-35. doi: 10.1038/pr.2015.266. Epub 2015 Dec 17.
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).
METHODS
One hundred and sixty-six extremely preterm infants were randomized to either experimental or control group. EEG was recorded at 64 h of age and blood samples were collected at 6 and 64 h of age.
RESULTS
One hundred and thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 vs. control 7.7 burst/min) or SEF95 (experimental 18.1 vs. control 18.0 Hz). The two groups did not differ regarding blood S100β, brain fatty acid-binding protein, and neuroketal concentrations at 6 and 64 h (n = 123 participants).
CONCLUSION
Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers.
背景
SafeBoosC二期多中心随机临床试验研究了在出生后72小时内，与对照组不采用近红外光谱（NIRS）数据及常规治疗相比，采用基于证据的治疗指南结合近红外光谱监测脑氧合的利弊。该试验表明，试验组脑缺氧负担显著降低。我们现在报告对脑电图（EEG）结果（爆发率和频谱边缘频率95%（SEF95））以及脑损伤血液生物标志物（S100β、脑脂肪酸结合蛋白和神经酮体）进行的盲法评估和分析的治疗效果。
方法
166例极早产儿被随机分为试验组或对照组。在64小时龄时记录脑电图，并在6小时和64小时龄时采集血样。
结果
共评估了133份脑电图。两组在爆发率（试验组7.2次/分钟 vs. 对照组7.7次/分钟）或SEF95（试验组18.1Hz vs. 对照组18.0Hz）方面无差异。在6小时和64小时时，两组在血S100β、脑脂肪酸结合蛋白和神经酮体浓度方面也无差异（n = 123名参与者）。
结论
以近红外光谱为指导的治疗降低了脑缺氧负担，而不影响脑电图或所选血液生物标志物。
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