Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19,601
- 试验地点
- 14
- 主要终点
- Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth
研究概览
简要总结
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.
The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.
详细描述
Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe 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
Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth
时间窗: Every 12 hr for 168 hr.
During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.
次要结局
- Predictive ability of an hour-specific TcB nomogram(At the 28 days after birth)
研究者
Zhangbin Yu
Principal Investigator
Nanjing Medical University