Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Characterization of microRNA in whole blood samples from neonates
研究概览
简要总结
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.
The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.
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
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life
排除标准
- 未提供
研究组 & 干预措施
Neonates with Congenital Heart Disease
Neonates born with severe Congenital Heart Disease undergoing corrective heart surgery within the first week of life under cardiopulmonary bypass at Boston Children's Hospital will be eligible for participation. As part of standard clinical care, neonates having cardiac surgery at Boston Children's Hospital have clinical labs drawn during and after surgery. All blood collected from neonates as part of this study will be discarded blood from those routine clinical samples. One sample will be taken before surgery and one sample will be taken after surgery.
干预措施: Collecting discarded blood samples (Other)
结局指标
主要结局
Characterization of microRNA in whole blood samples from neonates
时间窗: 2 days
isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways
次要结局
未报告次要终点
研究者
Koichi Yuki
Principal Investigator, MD
Boston Children's Hospital