Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Cytokine response
研究概览
简要总结
The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and bacteremia in NICU patients >3 days of age.
详细描述
All infants in the Newborn Intensive Care Unit greater than three days old that had blood cultures sent were eligible for this study. Left-over blood from the time at blood culture was collected for research purposes. Study personnel separated the serum and stored samples at -80 degrees until analysis. Samples were analyzed in batch for neonatal sepsis biomarkers using an antibody-coated microsphere assay with dual laser detection. Clinical information collected included symptoms prompting the blood culture, CBC and culture results, and antibiotic therapy.
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 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NICU patients > 3 days of age
排除标准
- •less than 3 days old or no waste blood available
结局指标
主要结局
Cytokine response
时间窗: Within the first twenty-four hours after blood cultures are obtained.
次要结局
- Heart rate characteristics(Within twenty-fours pre and post blood culture.)
研究者
Karen Fairchild, MD
Professor of Pediatrics
University of Virginia