Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 主要终点
- the bilirubin level of readministration for hyperbilirubinemia
研究概览
简要总结
In this prospective multi-center randomized clinical trial, a new follow-up strategy for neonatal jaundice after discharge will be evaluated. It is based on current risk factors of neonatal hyperbilirubinemia, added with the rate of bilirubin production (exhaled carbon monoxide measurement) as a new indicator,and incorporated with Internet Plus technology. Traditional methods following the Chinese guideline for neonatal hyperbilirubinemia were applied in the control group. The morbidity of BIND, the number of outpatient follow-up after discharge and the convenience will be compared between the two groups. The accuracy, effectiveness, safety and convenience of the study strategy will be testified.
详细描述
The eligible newborns will be randomized into two groups: the study group (innovative strategy) and the controlled group (traditional strategy).
The innovative strategy included the ETCOc measurement in the risk evaluating process and the Internet Plus approach in the follow-up process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age between 35(+0)~41(+6)
- •birth weight ≥ 2500 g
- •ethics approval obtained
- •parental consent obtained
排除标准
- •severe perinatal asphyxia
- •infectious diseases
- •persistent need for respiratory support
- •major congenital malformation
- •inborn errors of metabolism
- •pathological neonatal hyperbilirubinemia due to the defects of red blood cell membrane and erythrocyte enzyme
结局指标
主要结局
the bilirubin level of readministration for hyperbilirubinemia
时间窗: within 1 months
the average bilirubin level of infants, who are readmitted for hyperbilirubinemia
the incidence of acute bilirubin encephalitis
时间窗: within 2 week after birth
the number of infants with acute bilirubin encephalitis in each group
次要结局
- the time for the issue of jaundice follow-up(within 1 month)
- the cost for the issue of jaundice follow-up(within 1 month)