Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China

Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.

The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Device: Transcutaneous bilirubinometry

Detailed Description

Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.

• Study Type: Observational
• Enrollment (Actual): 19601

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
    • Xi'an, Shaanxi, China, 710003
      • Shaanxi Provincial Maternal and Child Health Hospital
  • Sichuan
    • Chendu, Sichuan, China
      • Sichuan Provincial People's Hospital
    • 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 thirteen hospital 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
Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth	During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.	Every 12 hr for 168 hr.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive ability of an hour-specific TcB nomogram	Evaluate the rate of rise of bilirubin for different time periods and percentile curves and to assess predictive ability of these percentile curves for hyperbilirubinemia, defined as requirement of phototherapy.	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: 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 4, 2013
• First Posted (Estimate): January 9, 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: Hyperbilirubinemia; Neonatal; Transcutaneous Bilirubin
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: NMU-FY2012-318