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

Summary

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.

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

DEVICE

Transcutaneous bilirubinometry

Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)

Sponsors & Collaborators

• Children's Hospital of Fudan University

  collaborator OTHER

• Nanjing Maternity and Child Health Care Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Jinlin Provincial Maternal and Child Health Hospital

  collaborator UNKNOWN

• Peking University Third Hospital

  collaborator OTHER

• Inner Mongolia Maternal and Child Health Care Hospital

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Guangdong Women and Children Hospital

  collaborator OTHER

• Guangxi Maternal and Child Health Hospital

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Guiyang Maternity and Child Health Care Hospital

  collaborator OTHER

• Nanjing Medical University

  lead OTHER

Principal Investigators

• Chao Chen, PhD · Children's Hospital of Fudan University

• Shuping Han, PhD · Nanjing Maternity and Child Health Care Hospital

• Zhangbin Yu, PhD · Nanjing Maternity and Child Health Care Hospital

• Chunming Jiang, PhD · First Affiliated Hospital of Harbin Medical University

• Yan Gao, PhD · Jinlin Provincial Maternal and Child Health Hospital

• Xiaomei Tong, PhD · Peking University Third Hospital

• Meihua Pu, PhD · Peking University Third Hospital

• Hongyun Wang, PhD · Inner Mongolia Maternal and Child Health Care Hospital

• Kezhan Liu, PhD · Shanxi Provincial Maternity and Children's Hospital

• Jin Wang, PhD · Children's Hospital of Fudan University

• Jimei Wang, PhD · Obstetrics & Gynecology Hospital of Fudan University

• Xiuyong Cheng, PhD · The First Affiliated Hospital of Zhengzhou University

• Jie Yang, PhD · Guangdong Women and Children Hospital

• Qiufen Wei, PhD · Guangxi Maternal and Child Health Hospital

• Zhankui Li, PhD · Shanxi Provincial Maternity and Children's Hospital

• Mingxia Li, PhD · First Affiliated Hospital of Xinjiang Medical University

• Ling Liu, PhD · Guiyang Maternity and Child Health Care Hospital

• Xiaofan Sun, MD · Nanjing Maternity and Child Health Care Hospital

Eligibility

Min Age

1 Day

Max Age

28 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• China

Study Locations