Clinical trial NCT03824990: Multi-center Clinical Study on Neonatal Hyperbilirubinemia
Official title: Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Improvement
Hyperbilirubinemia, Neonatal
Keywords: Quality improvement
Hyperbilirubinemia
screening
follow-up
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: JiLin Women and Children Health Hospital
name: Shandong Provincial Hospital
name: Shan Dong Qian Fo Shan Hospital
name: Shan Dong Liao Cheng Hospital
name: Guangxi Maternal and Child Health Hospital
name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Yin Chuan Maternity and Child Health Hospital
First posted: 2019-01-31
Enrollment: 20000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Eight hospitals in China will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia.

Detailed description: Through a prospective cohort study of healthy term and near-term infants, the study tries to truly reflect the epidemiology, intervention status, and outcomes of neonatal hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management model suitable for China's national condition, which can eventually reduce the incidence rate of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.

Eligibility criteria: Inclusion Criteria:

term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.

Exclusion Criteria:

Infants admitted to a higher level of intervention before discharge.

Primary outcomes:
measure: The incidence of bilirubin encephalopathy
timeFrame: 18 months
Secondary outcomes:
measure: The incidence of severe hyperbilirubinemia
timeFrame: 18 months
measure: The rate of lost to follow-up
timeFrame: 18 months
measure: The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia
timeFrame: 42 months
measure: Medical costs in patients with severe hyperbilirubinemia
timeFrame: 18 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: Shuping Han, PHD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Zhangbin Yu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: JiLin Women and Children Health Hospital
name: Zhiyong Sun, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qinhuangdao Maternal and Child Health Care Hospital
name: Haiyan Cai, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Yonghui Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shan Dong Qian Fo Shan Hospital
name: Xin Yuan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shan Dong Liao Cheng Hospital
name: Jin Qian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Jimei Wang, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangxi Maternal and Child Health Hospital
name: Wenyan Tang, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Maternal and Child Health Hospital
name: Qiufen Wei, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Zhankui Li, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yin Chuan Maternity and Child Health Hospital
name: Jie Gu, PHD
role: PRINCIPAL_INVESTIGATOR
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