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

NCT01763632 | Completed DMC

• 1 other identifier: NMU-FY2012-318
• Study Type: observational
• Target: 19,601
• Locations: 1 country
• Sites: 16

Brief 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

Keywords

Hyperbilirubinemia; Neonatal; Transcutaneous Bilirubin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predictive ability of an hour-specific TcB nomogram

  At the 28 days after birth

Interventions

Transcutaneous bilirubinometry DEVICE

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

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Term or late-preterm newborn infants from thirteen hospital in China were recruited.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing Medical University: lead
• Children's Hospital of Fudan University: collaborator
• Nanjing Maternity and Child Health Care Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Jinlin Provincial Maternal and Child Health Hospital: collaborator
• Peking University Third Hospital: collaborator
• Inner Mongolia Maternal and Child Health Care Hospital: collaborator
• Shanxi Provincial Maternity and Children's Hospital: collaborator
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Guangdong Women and Children Hospital: collaborator
• Guangxi Maternal and Child Health Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Guiyang Maternity and Child Health Care Hospital: collaborator

Study Sites (16)

Guangdong Maternal and Children's Hospital, Guangzhou Medical College

Guangzhou, Guangdong, 510010, China

Location

Guangxi Maternal and Child Health Hospital

Liuchow, Guangxi, 530003, China

Location

Guiyang Maternal and Child Health Hospital

Guiyang, Guizhou, 550003, China

Location

The First Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 410100, China

Location

Inner Mongolia Maternal and Child Health Care Hospital

Hohhot, Inner Mongolia, 010020, China

Location

Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210004, China

Location

Jinlin Provincial Maternal and Child Health Hospital

Changchun, Jilin, 130021, China

Location

Shaanxi Provincial Maternal and Child Health Hospital

Taiyuan, Shaanxi, 300013, China

Location

Shaanxi Provincial Maternal and Child Health Hospital

Xi'an, Shaanxi, 710003, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

The First Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

The Third Hospital of Peking University

Beijing, 100191, China

Location

Gynecology and Obstetrics Hospital, Fudan University

Shanghai, 200011, China

Location

Children's Hospital of Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chao Chen, PhD

  Children's Hospital of Fudan University

  STUDY DIRECTOR

• Shuping Han, PhD

  Nanjing Maternity and Child Health Care Hospital

  STUDY DIRECTOR

• Zhangbin Yu, PhD

  Nanjing Maternity and Child Health Care Hospital

  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

• Jimei Wang, PhD

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Xiuyong Cheng, PhD

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Jie Yang, PhD

  Guangdong Women and Children Hospital

  PRINCIPAL INVESTIGATOR

• Qiufen Wei, PhD

  Guangxi Maternal and Child Health Hospital

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

CN (16)