Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- sensitivity of lactate editing MR spectroscopy sequence (software) relative to that of the standard MR spectroscopy sequence.
研究概览
简要总结
Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is thought to affect approximately 0.2% of live births, and is associated with a high risk of mortality or long-term neurological disability.
Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely important both for clinical management and the evaluation of therapeutic approaches. According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome following HIE. However, for various technical reasons standard MRS methods do not offer optimal sensitivity for detecting lactate, which may potentially be improved with a custom lactate editing MRS sequence. In addition, while perfusion has also been suggested as a potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has not been evaluated in comparison with more established MR biomarkers. The aims of this study are:
- to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence (specialist software) relative to the standard point resolved (PRESS) MRS sequence for detecting lactate in neonates with suspected HIE.
- to evaluate the sensitivity and specificity of MR perfusion measures in comparison to MRS measures as predictors of neuro-developmental outcome at 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants (born at >36 weeks) with suspected perinatal asphyxia. Written informed consent from both parents.
排除标准
- •Prematurity (born at < 36 weeks). Lack of written informed consent from both parents.
结局指标
主要结局
sensitivity of lactate editing MR spectroscopy sequence (software) relative to that of the standard MR spectroscopy sequence.
时间窗: 12 months
The primary end-point will be reached when lactate and perfusion data have been collected from 30 neonates. The efficacy of the custom-MRS lactate editing sequence will be assessed relative to that of the standard MRS sequence for the detection of lactate (by comparing the lactate concentration (in mM) measured from the lactate edited MR spectra to that measured from the standard MR spectra).
次要结局
- prognostic accuracy (sensitivity and specificity) of MRI and MRS for predicting motor outcome at age 2(3 years)