Tau/P-Tau as Biomarkers of Anesthesia/Surgery-associated Neurocognitive Outcomes in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Blood Tau/P-Tau level before the surgery (baseline)
研究概览
简要总结
The proposed studies are aimed to measure Tau and P-Tau levels in pre- and postoperative blood, urine, feces and saliva, as well as to assess pre- and postoperative neurocognitive function in children (3 to 5 years old) who will have surgery under general anesthesia (single versus multiple exposures). The studies will establish a system to study biomarkers of the anesthesia/surgery-associated neurocognitive impairment in children and generate hypothesis that Tau or P-Tau serves as the biomarker of such neurocognitive impairment in children.
详细描述
This proposed studies have two specific aims:
- To investigate the relationship between pre-operative or postoperative blood levels of Tau or P-Tau and neurocognitive outcomes. The working hypothesis is that pre- and postoperative blood Tau/P-Tau levels are higher in participants who develop neurocognitive impairment than those in the participants who do not develop it. The investigators will perform neurocognitive test before the surgery and then at 12 months after the surgery. The investigators will collect pre-operative and postoperative blood and measure Tau/P-Tau levels in the blood. Finally, the association of the changes in the Tau/P-Tau levels and neurocognitive scores will be assessed. More importantly, this Aim will establish an eligible: recruit ratio, retention rates, safety of the protocol, and power calculation, which will provide crucial information to guide better design of future R01 study.
- To perform the feasibility studies of measuring Tau or P-Tau in urine, feces and saliva of the participants. The working hypothesis is that Tau/P-Tau in urine, feces or saliva of children can be measured. The investigators will use the nanobeam to measure Tau/P-Tau levels before and after the surgery. The investigators will then determine whether urine, feces and saliva can be used for the future studies to develop Tau/P-Tau as the biomarker of anesthesia/surgery-associated neurocognitive impairment in children.
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
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between age 3 and 5 at the time of the first neurocognitive test;
- •scheduled for surgery under general anesthesia
排除标准
- •gestational age less than 36 weeks;
- •congenital heart disease that has required surgery or will require surgery or that requires ongoing pharmacotherapy;
- •known chromosomal abnormality or any other known acquired or congenital abnormalities which are likely to affect neurodevelopment;
- •known neurological injury such as cystic periventricular leukomalacia or grade 3 or 4 intra-ventricular hemorrhage (+/- post hemorrhage ventricular dilatation);
- •children for whom follow-up would be difficult for geographic or psychosocial reasons;
- •non-native English speaker (both child and parents);
- •severe visual or auditory disorder.
结局指标
主要结局
Blood Tau/P-Tau level before the surgery (baseline)
时间窗: Before the surgery
300 ul venous blood before the surgery will be collected from the inserted intravenous catheter to measure the levels of Tau/P-Tau
Blood Tau/P-Tau level at postoperative 3 hours
时间窗: At 3 hours after the surgery
300 ul venous blood at 3 hours after the surgery will be collected from the inserted intravenous catheter to measure the levels of Tau/P-Tau
Blood Tau/P-Tau level at postoperative 6 hours
时间窗: At 6 hours after the surgery
300 ul venous blood at 6 hours after the surgery will be collected from the inserted intravenous catheter to measure the levels of Tau/P-Tau
次要结局
- Neurocognitive function before the surgery (baseline)(Before the surgery)
- Saliva Tau/P-Tau level before the surgery (baseline)(Before the surgery)
- Feces Tau/P-Tau level before the surgery (baseline)(Before the surgery)
- Urine Tau/P-Tau level before the surgery (baseline)(Before the surgery)
- Neurocognitive function at postoperative one year(At postoperative one year)
- Feces Tau/P-Tau level at postoperative one day(At postoperative one day)
- Urine Tau/P-Tau level at postoperative one day(At postoperative one day)
- Saliva Tau/P-Tau level at postoperative one day(At postoperative one day)
研究者
Zhongcong Xie
Professor of Anesthesia
Massachusetts General Hospital