Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- The incidence of bilirubin encephalopathy
研究概览
简要总结
Eight hospitals in China will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia.
详细描述
Through a prospective cohort study of healthy term and near-term infants, the study tries to truly reflect the epidemiology, intervention status, and outcomes of neonatal hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management model suitable for China's national condition, which can eventually reduce the incidence rate of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.
排除标准
- •Infants admitted to a higher level of intervention before discharge.
结局指标
主要结局
The incidence of bilirubin encephalopathy
时间窗: 18 months
次要结局
- The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia(42 months)
- Medical costs in patients with severe hyperbilirubinemia(18 months)
- The incidence of severe hyperbilirubinemia(18 months)
- The rate of lost to follow-up(18 months)
研究者
Zhangbin Yu
Nan Jing Maternity and Child Health Care Hospital
Nanjing Medical University