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临床试验/NCT01679275
NCT01679275已完成不适用

Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2012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
57
试验地点
1
主要终点
Neurodevelopmental follow up at 24 months

研究概览

简要总结

Congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. The causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. They relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. In this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.

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 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • neonates with admission on neonatal intensive care unit with congenital heart disease.

排除标准

  • No informed consent. (for the long term neurodevelopmental FU)
  • no cerebral oxygen saturation in the first 3 day's of life
  • gestational age < 37 weeks

结局指标

主要结局

Neurodevelopmental follow up at 24 months

时间窗: 24 months

Neurodevelopmental assessment at 24 months using Bayley scales of infant development II

次要结局

  • Association of cerebrovascular changes with short term outcome(time frame of 1 admission)
  • cerebrovascular changes in the transitional phase(first 3 days of life)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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