Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network：A Multicentrd, Prospective, Open, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- To record the TCB values of Chinese newborns within 28 days after birth.
研究概览
简要总结
At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.
详细描述
This is a prospective cohort study of healthy term and near-term infants. The mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. Firstly，the TCB values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in China. Secondly, by establishing an online registry for severe hyperbilirubinemia and "Follow up of jaundice" on Wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. Lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 near-term neonates with gestational age ≥35w and birth weight ≥2000g.
排除标准
- •Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.
结局指标
主要结局
To record the TCB values of Chinese newborns within 28 days after birth.
时间窗: 12 months
Transcutaneous bilirubin (TcB) values will be recorded so as to establish transcutaneous bilirubin nomogram in healthy Chinese term and late-preterm infants at \<28 days of age.
The comprehensive prognosis of infants
时间窗: 60 months
To investigate the comprehensive prognosis of infants with severe hyperbilirubinemia at the corrected age of 2 years in a real-world setting in Jiangsu Province.
次要结局
- The incidence of neurological sequelae.(60 months)
- Risk factors of extreme hyperbilirubinemia(36 months)
- The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.(36 months)
研究者
Zhangbin Yu
Principal Investigator of Nan Jing Maternity and Child Health Care Hospital
Nanjing Medical University