Integrating neuroimaging biomarkers into the multicentre, high-dose erythropoietin for asphyxia and encephalopathy (HEAL) trial: rationale, protocol and harmonisation.
Integrating neuroimaging biomarkers into the multicentre, high-dose erythropoietin for asphyxia and encephalopathy (HEAL) trial: rationale, protocol and harmonisation.
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DOI：
10.1136/bmjopen-2020-043852
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发表时间：
2021-04-22
期刊：
影响因子：
2.9
通讯作者：
HEAL Study Group
中科院分区：
文献类型：
--
作者：
Wisnowski JL;Bluml S;Panigrahy A;Mathur AM;Berman J;Chen PK;Dix J;Flynn T;Fricke S;Friedman SD;Head HW;Ho CY;Kline-Fath B;Oveson M;Patterson R;Pruthi S;Rollins N;Ramos YM;Rampton J;Rusin J;Shaw DW;Smith M;Tkach J;Vasanawala S;Vossough A;Whitehead MT;Xu D;Yeom K;Comstock B;Heagerty PJ;Juul SE;Wu YW;McKinstry RC;HEAL Study Group
MRI 和 MR 波谱 (MRS) 为患有缺氧缺血性脑病的新生儿提供脑损伤和治疗反应的早期生物标志物。尽管如此，将神经影像生物标志物纳入多中心随机对照试验仍面临挑战。在本文中，我们提供了将 MRI 和 MRS 生物标志物纳入多部位 III 期高剂量促红细胞生成素治疗窒息和脑病 (HEAL) 试验、MRI/S 方案的基本原理，并描述了用于协调多个 MRI 平台的策略。参加多中心 HEAL 试验的患有中度或重度脑病的新生儿在 96 至 144 小时之间使用标准化神经影像方案接受 MRI 和 MRS。 MRI 和 MRS 数据经过集中处理，用于确定脑损伤评分以及乳酸和 n-乙酰天冬氨酸的定量测量。通过标准化实现协调，从而减少站点内和站点间的差异、实时质量保证监控和体模扫描。在参与 HEAL 之前，每个参与地点都获得了 IRB 的批准，并获得了家长的书面同意。美国国立卫生研究院指定的数据安全监察委员会和医疗监察员提供额外的监督。 NCT02811263；预结果。
MRI and MR spectroscopy (MRS) provide early biomarkers of brain injury and treatment response in neonates with hypoxic-ischaemic encephalopathy). Still, there are challenges to incorporating neuroimaging biomarkers into multisite randomised controlled trials. In this paper, we provide the rationale for incorporating MRI and MRS biomarkers into the multisite, phase III high-dose erythropoietin for asphyxia and encephalopathy (HEAL) Trial, the MRI/S protocol and describe the strategies used for harmonisation across multiple MRI platforms. Neonates with moderate or severe encephalopathy enrolled in the multisite HEAL trial undergo MRI and MRS between 96 and 144 hours of age using standardised neuroimaging protocols. MRI and MRS data are processed centrally and used to determine a brain injury score and quantitative measures of lactate and n-acetylaspartate. Harmonisation is achieved through standardisation—thereby reducing intrasite and intersite variance, real-time quality assurance monitoring and phantom scans. IRB approval was obtained at each participating site and written consent obtained from parents prior to participation in HEAL. Additional oversight is provided by an National Institutes of Health-appointed data safety monitoring board and medical monitor. NCT02811263; Pre-result.
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影响因子：
19.7
作者：
Alderliesten, Thomas;de Vries, Linda S.;Groenendaal, Floris
通讯作者：
Groenendaal, Floris
DOI：
10.1097/rmr.0b013e31821e568f
发表时间：
2010-04
期刊：
Topics in magnetic resonance imaging : TMRI
影响因子：
--
作者：
Alger JR
通讯作者：
Alger JR
影响因子：
3.6
作者：
Gano, Dawn;Chau, Vann;Miller, Steven P.
通讯作者：
Miller, Steven P.
影响因子：
2.8
作者：
Gorelik, Natalia;Faingold, Ricardo;Epelman, Monica
通讯作者：
Epelman, Monica
影响因子：
3.7
作者：
Blüml S;Wisnowski JL;Nelson MD Jr;Paquette L;Panigrahy A
通讯作者：
Panigrahy A