Multicenter Prospective Study on the Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13,157
- 试验地点
- 14
- 主要终点
- The incidence of severe neonatal hyperbilirubinemia
研究概览
简要总结
Thirteen hospitals in China will participate in the study, which aims to provide data on serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.
We hypothesize that the study can be value in identifying and implementing strategies for risk reduction.
详细描述
Neonatal hyperbilirubinemia resulting in clinical jaundice is a common problem among infants, particularly during the first weeks of life.
Information about the incidence and risk factors of neonatal jaundice is not available from China where is one of the highest countries of the incidence of severe neonatal hyperbilirubinemia.
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 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.
排除标准
- •All sick newborn infants who were admitted to the intensive care unit.
结局指标
主要结局
The incidence of severe neonatal hyperbilirubinemia
时间窗: At the 28 days after birth
Significant hyperbilirubinemia was defined as any TSB level that exceeded the hour-specific threshold value for phototherapy, according to the guidelines presented by the American Academy of Pediatrics.
次要结局
- Number of participants with risk factors associated with severe neonatal hyperbilirubinemia(At the 28 days after birth)
研究者
Zhangbin Yu
Principal Investigator
Nanjing Medical University