Development and Validation of a Clinical Risk Score to Predict the Occurrence of Bloody Stool in Hospitalized Neonates in Non-neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- a Clinical Risk Score
研究概览
简要总结
Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization.
NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.
详细描述
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.
Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is.
Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated 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 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than or equal to 35 weeks' gestational age(GA)
- •less than or equal to 28 days
- •non-neonatal intensive care unit ward
排除标准
- •parents' rejection
- •main congenital malformation
结局指标
主要结局
a Clinical Risk Score
时间窗: up to 28 days or discharge from hospital
a Clinical Risk Score is developed in a retrospective cohort
validation of a Clinical Risk Score
时间窗: up to 28 days or discharge from hospital
a Clinical Risk Score is validation in another prospective cohort
次要结局
未报告次要终点
研究者
Chen Long,MD
director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University