Clinical trial NCT04251286: Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network
Official title: Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network：A Multicentrd, Prospective, Open, Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hyperbilirubinemia
screening
follow-up
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Xuzhou Maternity and Child Health Care Hospital
name: Jiangsu Women and Children Health Hospital
name: Changzhou Maternal and Child Care Hospital
name: Lianyungang Maternity and Child Health Care Hospital
name: Affiliated Hospital of Jiangsu University
name: Suqian First Hospital
name: Jiangyin People's Hospital
name: Nantong Maternity and Child Health Care Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Taizhou People's Hospital
name: Yangzhou Maternity and Child Health Care Hospital
name: Yangzhou University
First posted: 2020-01-31
Enrollment: 4000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To record the TCB values of Chinese newborns within 28 days after birth.
timeFrame: 12 months
measure: The comprehensive prognosis of infants
timeFrame: 60 months
Secondary outcomes:
measure: Risk factors of extreme hyperbilirubinemia
timeFrame: 36 months
measure: The incidence of neurological sequelae.
timeFrame: 60 months
measure: The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.
timeFrame: 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Han Shuping, PHD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Yu Zhangbin, PHD
role: STUDY_DIRECTOR
affiliation: Xuzhou Maternity and Child Health Care Hospital
name: Deng Xiaoyi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Women and Children Health Hospital
name: Hu Yuhua, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhou Maternal and Child Care Hospital
name: Wang Jinxiu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Maternity and Child Health Care Hospital
name: Li Qianqian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lianyungang Maternity and Child Health Care Hospital
name: Gao Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiangsu University
name: Lu Hongyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suqian First Hospital
name: Zhang Jia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangyin People's Hospital
name: Wan Jun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantong Maternity and Child Health Care Hospital
name: Li Shuangshuang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangzhou University
name: Wu Mingfu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangzhou Maternity and Child Health Care Hospital
name: Wu Xinping, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Wang Jun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou People's Hospital
name: Xue Mei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.