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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Children's Hospital of Fudan University
Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
The First Hospital of Harbin Medical University
First Hospital of Jilin University
Peking University Third Hospital
Inner Mongolia Maternal and Child Health Care Hospital
Shanxi Provincial Maternity and Children's Hospital
Maternity Hospital of Fudan University
The First Affiliated Hospital of Zhengzhou University
Xiangya Hospital of Central South University
Guangdong Provincial Maternal and Child Health Hospital
Guangxi Maternal and Child Health Hospital
Shaanxi Maternal and Child Health Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Kunming Medical University
Guiyang Maternity and Child Health Care Hospital
Information provided by (Responsible Party):
Zhangbin Yu, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01763632
First received: January 2, 2013
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

Seventeen 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.


Condition Intervention
Hyperbilirubinemia, Neonatal
Device: Transcutaneous bilirubinometry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth [ Time Frame: Every 12 hr for 168 hr. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Predictive ability of an hour-specific TcB nomogram [ Time Frame: At the 28 days after birth ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 14000
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcutaneous bilirubinometry
    Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)
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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763632

Locations
China, Guangdong
Guangdong Provincial Maternal and Child Health Hospital
Guangzhou, Guangdong, China, 510010
China, Guangxi
Guangxi Maternal and Child Health Hospital
Liuzhou, Guangxi, China, 530003
China, Guizhou
Guiyang Maternal and Child Health Hospital
Guiyang, Guizhou, China, 550003
China, Heilongjiang
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 410100
China, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
China, Inner Mongolia
Inner Mongolia Maternal and Child Health Care Hospital
Hohhot Shi, Inner Mongolia, China, 010020
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210004
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Shaanxi
Shaanxi Provincial Maternal and Child Health Hospital
Taiyuan, Shaanxi, China, 300013
Shaanxi Maternal and Child Health Hospital
Xi'an, Shaanxi, China, 710003
China, Sichuan
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
China, Xinjiang
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
China, Yunnan
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
China
The Third Hospital of Peking University
Beijing, China, 100191
Maternity Hospital of Fudan University
Shanghai, China, 200011
Children's Hospital of Fudan University
Shanghai, China, 200032
Sponsors and Collaborators
Nanjing Medical University
Children's Hospital of Fudan University
Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
The First Hospital of Harbin Medical University
First Hospital of Jilin University
Peking University Third Hospital
Inner Mongolia Maternal and Child Health Care Hospital
Shanxi Provincial Maternity and Children's Hospital
Maternity Hospital of Fudan University
The First Affiliated Hospital of Zhengzhou University
Xiangya Hospital of Central South University
Guangdong Provincial Maternal and Child Health Hospital
Guangxi Maternal and Child Health Hospital
Shaanxi Maternal and Child Health Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Kunming Medical University
Guiyang Maternity and Child Health Care Hospital
Investigators
Study Director: Chao Chen, PhD Children's Hospital of Fudan University
Study Director: Shuping Han, PhD Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
Principal Investigator: Zhangbin Yu, PhD Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
Principal Investigator: Chunming Jiang, PhD The First Hospital of Harbin Medical University
Principal Investigator: Chaoying Yan, PhD First Hospital of Jilin University
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 Maternity Hospital of Fudan University
Principal Investigator: Xiuyong Cheng, PhD The First Affiliated Hospital of Zhengzhou University
Principal Investigator: Shaojie Yue, PhD Xiangya Hospital of Central South University
Principal Investigator: Jie Yang, PhD Guangdong Provincial Maternal and Child Health Hospital
Principal Investigator: Qiufen Wei, PhD Guangxi Maternal and Child Health Hospital
Principal Investigator: Zhankui Li, PhD Shaanxi Maternal and Child Health 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: Kun Liang, PhD The First Affiliated Hospital of Kunming 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 of Nanjing Medical University
  More Information

No publications provided

Responsible Party: Zhangbin Yu, Principal Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01763632     History of Changes
Other Study ID Numbers: NMU-FY2012-318
Study First Received: January 2, 2013
Last Updated: January 4, 2013
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Hyperbilirubinemia
Neonatal
Transcutaneous Bilirubin

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014