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临床试验/NCT00131859
NCT00131859已完成不适用

Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Diffusion-tensor imaging differences between brain injured cases and controls without brain injury

研究概览

简要总结

The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.

详细描述

Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight < 1500 grams will be offered DTI, and infants > 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
23 Weeks 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All infants born at our hospital at < 1500 grams
  • All infants born at our hospital at > 1500 grams with brain injury or severe metabolic acidosis

排除标准

  • Major congenital malformations
  • Chromosomal abnormality

结局指标

主要结局

Diffusion-tensor imaging differences between brain injured cases and controls without brain injury

时间窗: 2 years

次要结局

  • Umbilical cord gas results(2 years)
  • Placental pathology(2 years)
  • Electronic fetal monitoring(2 years)
  • Nucleated red blood cells(2 years)

研究者

申办方类型
Other

研究点 (1)

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