Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Clinical outcome
研究概览
简要总结
The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.
详细描述
Hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral blood flow drop during perinatal period. It is the leading cause of neonatal encephalopathy, and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental outcome. Usual care brain MRI is critically important in the diagnosis and prognosis. Lasting about 30 to 40 minutes, MRI exam includes successive sequences providing complementary information but none relatively to brain perfusion. Perfusion MRI without contrast media injection is possible using Arterial Spin Labeling (ASL) sequence. ASL is highly suitable for neonates, noninvasiveness, and lasts only 5 minutes. However, only one study assessed ASL as a prognostic factor. The purpose of the study is therefore to perform ASL sequence within usual care brain MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g.
- •presenting with perinatal asphyxia defined as combination of:
- •an acute perinatal event (such as placental abruption, cord prolapse, and/or severe foetal heart rate abnormalities);
- •and at least one of the following criteria:
- •Apgar score ≤ 5 at 10 minutes of life,
- •mask ventilation or intubation at 10 minutes of life,
- •metabolic acidosis defined as pH < 7 or base deficit ≥ 16 mmol/L or lactates ≥ 11 mmol/L within the first 60 minutes of life on cord or other arterial venous or capillary blood sample.
- •patient treated or not with therapeutic hypothermia for 72 hours.
- •affiliated patient or beneficiary of a social security scheme.
- •informed and signed parental consent.
排除标准
- •perinatal arterial ischemic stroke.
- •congenital neuro-metabolic disorder.
- •severe malformative abnormalities.
- •MRI contra-indication.
- •Poor understanding of the holders of parental authority
研究组 & 干预措施
Arterial Spin Labeling sequence
ASL sequence added to the usual care brain MRI
干预措施: Arterial Spin Labeling sequence (Device)
结局指标
主要结局
Clinical outcome
时间窗: 3 months of life (Month 3)
judged as favorable, or as adverse in case of death or cerebral palsy
次要结局
- Clinical outcome(Month 6, Month 12)
- Prognostic performances of ASL(Baseline)
- Quality of ASL sequences(Baseline)
- Inter-observer agreement of the interpretation of the perfusion data(Baseline)