Integrated Physiomarker, Biomarker and Clinical Predictive Analytics for Early Warning of Sepsis and Necrotizing Enterocolitis in Very Low Birth Weight Infants: Pilot Randomized Clinical Trial to Test Feasibility of Integrated Predictive Monitoring for Sepsis and NEC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number of Participants With Sepsis or Necrotizing Enterocolitis
研究概览
简要总结
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 1500 grams at birth
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Sepsis or Necrotizing Enterocolitis
时间窗: From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old
Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither.
次要结局
未报告次要终点
研究者
Brynne Sullivan
Associate Professor of Pediatrics
University of Virginia