Hyperbilirubinemia, Neonatal
Conditions
Keywords
Hyperbilirubinemia, screening, follow-up
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Xuzhou Maternity and Child Health Care Hospital
Jiangsu Women and Children Health Hospital
Changzhou Maternal and Child Care Hospital
Lianyungang Maternity and Child Health Care Hospital
Affiliated Hospital of Jiangsu University
Suqian First Hospital
Jiangyin People's Hospital
Nantong Maternity and Child Health Care Hospital
The Affiliated Hospital of Xuzhou Medical University
Taizhou People's Hospital
Yangzhou Maternity and Child Health Care Hospital
Yangzhou University
Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* Term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.
Exclusion criteria
* Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To record the TCB values of Chinese newborns within 28 days after birth. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors of extreme hyperbilirubinemia | 36 months | Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL. |
| The incidence of neurological sequelae. | 60 months | 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 |
| The completion rate of each jaundice management measure for severe hyperbilirubinemia cases. | 36 months | To calculate the completion rate of each jaundice management measure for severe hyperbilirubinemia cases, whose total serum bilirubin are more than 20mg/dL |
Countries
China
Contacts
Primary ContactHan Shuping, PHD
Backup ContactYu Zhangbin, PHD
Outcome results
None listed