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| Name | Class |
|---|---|
| Xuzhou Maternity and Child Health Care Hospital | OTHER |
| Jiangsu Women and Children Health Hospital | UNKNOWN |
| Changzhou Maternal and Child Care Hospital | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| To record the TCB values of Chinese newborns within 28 days after birth. | 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. | 12 months |
| The comprehensive prognosis of infants | 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. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors of extreme hyperbilirubinemia | Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL. | 36 months |
| The incidence of neurological sequelae. | To assess the clinical outcome at 2 years of corrected age in cases treated with and without exchange transfusion when TSB is at a level of the threshold |
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Inclusion Criteria:
Exclusion Criteria:
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For the research on the natural history of jaundice via mobile network, the selected population is healthy newborns with gestational age ≥35 weeks and weight ≥2000g, and those without phototherapy or hospital intervention. For the study of the online registry for severe hyperbilirubinemia, the study population is gestational age ≥35 weeks, weight ≥2000g, only hospitalized for jaundice, and the serum total bilirubin reached the threshold of exchange transfusion (≤3 days) or the serum total bilirubin ≥20mg / dl (>3 days).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Shuping, PHD | Contact | +86-025-52226561 | shupinghan@njmu.edu.cn | |
| Yu Zhangbin, PHD | Contact | +86-025-52226567 | yuzhangbin@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Han Shuping, PHD | Nanjing Maternity and Child Health Care Hospital | Study Director |
| Yu Zhangbin, PHD | Nanjing Maternity and Child Health Care Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternity and Child Health Care Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33550236 | Derived | Li Q, Deng X, Yan J, Sun X, Dong X, Chen X, Han S, Huo J, Yu Z. Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study. BMJ Open. 2021 Feb 5;11(2):e040797. doi: 10.1136/bmjopen-2020-040797. |
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The study is an open project, and the collected data and information will be provided to all participating centers after review by the data management committee. Anyone interested in this research can contact us directly.
The Study Protocol will be shared after the publication until the end of the study.
All participating centres
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lianyungang Maternity and Child Health Care Hospital |
| UNKNOWN |
| Affiliated Hospital of Jiangsu University | OTHER |
| Suqian First Hospital | OTHER |
| Jiangyin People's Hospital | OTHER |
| Nantong Maternity and Child Health Care Hospital | UNKNOWN |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| Jiangsu Taizhou People's Hospital | OTHER |
| Yangzhou Maternity and Child Health Care Hospital | UNKNOWN |
| Yangzhou University | OTHER |
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| 60 months |
| The completion rate of each jaundice management measure for severe hyperbilirubinemia cases. | To calculate the completion rate of each jaundice management measure for severe hyperbilirubinemia cases, whose total serum bilirubin are more than 20mg/dL | 36 months |
| Deng Xiaoyi, MD |
| Xuzhou Maternity and Child Health Care Hospital |
| Principal Investigator |
| Hu Yuhua, PHD | Jiangsu Women and Children Health Hospital | Principal Investigator |
| Wang Jinxiu, PHD | Changzhou Maternal and Child Care Hospital | Principal Investigator |
| Li Qianqian, MD | Xuzhou Maternity and Child Health Care Hospital | Principal Investigator |
| Gao Yan, MD | Lianyungang Maternity and Child Health Care Hospital | Principal Investigator |
| Lu Hongyan, MD | Affiliated Hospital of Jiangsu University | Principal Investigator |
| Zhang Jia, MD | Suqian First Hospital | Principal Investigator |
| Wan Jun, MD | Jiangyin People's Hospital | Principal Investigator |
| Li Shuangshuang, MD | Nantong Maternity and Child Health Care Hospital | Principal Investigator |
| Wu Mingfu, MD | Yangzhou University | Principal Investigator |
| Wu Xinping, MD | Yangzhou Maternity and Child Health Care Hospital | Principal Investigator |
| Wang Jun, MD | The Affiliated Hospital of Xuzhou Medical University | Principal Investigator |
| Xue Mei, MD | Jiangsu Taizhou People's Hospital | Principal Investigator |