Florida Neonatal Neurologic Network
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
研究概览
简要总结
Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.
详细描述
The purpose of this study is to create a detailed medical and sample database of infants born with HIE. Both the medical information and the samples are de-identified. Any future studies performed with the data and samples will receive Institutional Review Board (IRB) approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational Age greater than or equal to 35 weeks gestation
- •Birth weight greater than or equal to 1.8 kg
- •Less than or equal to 6 hours since insult occurred
- •Severe hypoxic-ischemic encepholopathy (HIE)
排除标准
- •Presence of lethal chromosomal abnormalities
- •Severe IUGR
- •Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
研究组 & 干预措施
Database Entry/Biospecimen Collection
Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.
干预措施: Database Entry/Biospecimen Collection (Other)
结局指标
主要结局
Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
时间窗: 2 years
Measure HIE biomarker levels in blood samples obtained in infants born with HIE.
次要结局
未报告次要终点