Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age
研究概览
简要总结
Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.
详细描述
Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The developmental assessment tool that will be used is called the Bayley Scales of Infant and Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will then be compared to the child's HIE biomarkers concentrations already obtained at birth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children already enrolled in IRB#504-2011
- •18-20 months of age
排除标准
- 未提供
结局指标
主要结局
Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age
时间窗: 2 years
Compare Developmental Outcomes to HIE Biomarker concentrations at birth
次要结局
未报告次要终点