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

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:
NCT01762189
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

Seventeen 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.


Condition Intervention
Hyperbilirubinemia, Neonatal
Procedure: Phototherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Study on the Incidence of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • The incidence of severe neonatal hyperbilirubinemia [ Time Frame: At the 28 days after birth ] [ Designated as safety issue: Yes ]
    Significant hyperbilirubinemia was defined as TSB above the 95th percentile for age (high-risk zone) according to the hour-specific percentile nomogram presented by the American Academy of Pediatrics.


Secondary Outcome Measures:
  • Number of participants with risk factors associated with severe neonatal hyperbilirubinemia [ Time Frame: At the 28 days after birth ] [ Designated as safety issue: No ]
    The risk factors recognized to be associated with severe hyperbilirubinemia in newborns have included jaundice in the first 24 hr of life, jaundice noted before discharge from hospital, a sibling who had jaundice treated with phototherapy, late-preterm gestational age of 35-36 weeks, the presence of infant bruising or cephalhematoma, rhesus and ABO incompatibility, et al.


Estimated Enrollment: 7000
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:
    Procedure: Phototherapy
    The decision to use phototherapy conformed to the hour-specific threshold value for phototherapy presented by the American Academy of Pediatrics guidelines and was not at the discretion of the investigators.
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 of neonatal jaundice is not available from China where is one of the highest countries of the incidence of severe neonatal 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 hospitals 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: NCT01762189

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: NCT01762189     History of Changes
Other Study ID Numbers: NMU-FY2012-319
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Hyperbilirubinemia
Neonatal
Incidence
Risk factors

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 01, 2014