The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Multicenter Prospective Study on the Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Thirteen hospitals in China will participate in the study, which aims to provide data on serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.

We hypothesize that the study can be value in identifying and implementing strategies for risk reduction.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Procedure: Phototherapy

Detailed Description

Neonatal hyperbilirubinemia resulting in clinical jaundice is a common problem among infants, particularly during the first weeks of life.

Information about the incidence and risk factors of neonatal jaundice is not available from China where is one of the highest countries of the incidence of severe neonatal hyperbilirubinemia.

• Study Type: Observational
• Enrollment (Actual): 13157

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • The Third Hospital of Peking University
  • Shanghai, China, 200032
    • Children's Hospital of Fudan University
  • Shanghai, China, 200011
    • Gynecology and Obstetrics Hospital, Fudan University
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Guangdong Maternal and Children's Hospital, Guangzhou Medical College
  • Guangxi
    • Liuzhou, Guangxi, China, 530003
      • Guangxi Maternal and Child Health Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550003
      • Guiyang Maternal and Child Health Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 410100
      • The First Affiliated Hospital of Zhengzhou University
  • Inner Mongolia
    • Hohhot Shi, Inner Mongolia, China, 010020
      • Inner Mongolia Maternal and Child Health Care Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jinlin Provincial Maternal and Child Health Hospital
  • Shaanxi
    • Taiyuan, Shaanxi, China, 300013
      • Shaanxi Provincial Maternal and Child Health Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830054
      • The First Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Term or late-preterm newborn infants from Seventeen hospitals in China were recruited.

Description

Inclusion Criteria:

Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.

Exclusion Criteria:

All sick newborn infants who were admitted to the intensive care unit.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of severe neonatal hyperbilirubinemia	Significant hyperbilirubinemia was defined as any TSB level that exceeded the hour-specific threshold value for phototherapy, according to the guidelines presented by the American Academy of Pediatrics.	At the 28 days after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with risk factors associated with severe neonatal hyperbilirubinemia	The risk factors recognized to be associated with significant hyperbilirubinemia in newborns have included gestational age, weight for Gestational Age, delivery mode, gender, previous infant had phototherapy, bruising/cephalahematoma, feeding mode, excessive body weight loss, and early discharge, et al.	At the 28 days after birth

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: Peking University Third Hospital; The First Affiliated Hospital of Zhengzhou University; Children's Hospital of Fudan University; Obstetrics & Gynecology Hospital of Fudan University; First Affiliated Hospital of Xinjiang Medical University; Sichuan Provincial People's Hospital; Nanjing Maternity and Child Health Care Hospital; First Affiliated Hospital of Harbin Medical University; Guangdong Women and Children Hospital; Shanxi Provincial Maternity and Children's Hospital; Guiyang Maternity and Child Health Care Hospital; Guangxi Maternal and Child Health Hospital; Inner Mongolia Maternal and Child Health Care Hospital; Jinlin Provincial Maternal and Child Health Hospital
• Investigators: Principal Investigator: Jie Yang, PHD, Guangdong Women and Children Hospital; Study Director: Chao Chen, PhD, Children's Hospital of Fudan University; Principal Investigator: Chunming Jiang, PhD, First Affiliated Hospital of Harbin Medical University; Principal Investigator: Yan Gao, PhD, Jinlin Provincial Maternal and Child Health Hospital; Principal Investigator: Xiaomei Tong, PhD, Peking University Third Hospital; Principal Investigator: Meihua Pu, PhD, Peking University Third Hospital; Principal Investigator: Hongyun Wang, PhD, Inner Mongolia Maternal and Child Health Care Hospital; Principal Investigator: Kezhan Liu, PhD, Shanxi Provincial Maternity and Children's Hospital; Principal Investigator: Jin Wang, PhD, Children's Hospital of Fudan University; Principal Investigator: Xiuyong Cheng, PhD, The First Affiliated Hospital of Zhengzhou University; Principal Investigator: Zhankui Li, PhD, Shanxi Provincial Maternity and Children's Hospital; Principal Investigator: Mingxia Li, PhD, First Affiliated Hospital of Xinjiang Medical University; Principal Investigator: Changhui Chen, PhD, Sichuan Provincial People's Hospital; Principal Investigator: Ling Liu, PhD, Guiyang Maternity and Child Health Care Hospital; Principal Investigator: Xiaofan Sun, MD, Nanjing Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 25, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Incidence; Risk factors; Hyperbilirubinemia; Neonatal
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: NMU-FY2012-319