Assessment of Score System to Predict the Need for Surgery in Newborn Infants With Two and More Grades of NEC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- accuracy of the score system for predicting the need of surgery
研究概览
简要总结
Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.
详细描述
Necrotizing enterocolitis(NEC) is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.
Two and more grades of NEC in newborn infant is a urgent condition, and whether or not operation is difficult to predict.
Here, the investigators develop a score system including five parameters(abdominal circumference, base excess, heart rate, severities of respiratory distress, sepsis) in one retrospective cohort, and the score system is used and assessed to predict the need for surgery in another prospective cohort.
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 Hour 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •two and more of NEC is diagnosed in the newborn infants
- •on the time of diagnosis for NEC both the surgery and non-surgery are reasonable according the surgeon's suggestions
排除标准
- •pneumoperitoneum
- •refusing to take part in the study according to parents' decision
结局指标
主要结局
accuracy of the score system for predicting the need of surgery
时间窗: before surgery
accuracy of the score system for predicting the need of surgery is assessed
negative predictive value of the score system for predicting the need of surgery
时间窗: before surgery
negative predictive value of the score system for predicting the need of surgery is assessed
positive likelihood ratio of the score system for predicting the need of surgery
时间窗: before surgery
positive likelihood ratio of the score system for predicting the need of surgery is assessed
sensitivity of the score system for predicting the need of surgery
时间窗: before surgery
sensitivity of the score system for predicting the need of surgery is assessed
specificity of the score system for predicting the need of surgery
时间窗: before surgery
specificity of the score system for predicting the need of surgery is assessed
negative likelihood ratio of the score system for predicting the need of surgery
时间窗: before surgery
negative likelihood ratio of the score system for predicting the need of surgery is assessed
positive predictive value of the score system for predicting the need of surgery
时间窗: before surgery
positive predictive value of the score system for predicting the need of surgery is assessed
次要结局
未报告次要终点
研究者
Chen Long,MD
director
Children's Hospital of Chongqing Medical University