Clinical trial NCT01763632: Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
Official title: Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hyperbilirubinemia
Neonatal
Transcutaneous Bilirubin
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Fudan University
name: Nanjing Maternity and Child Health Care Hospital
name: First Affiliated Hospital of Harbin Medical University
name: Jinlin Provincial Maternal and Child Health Hospital
name: Peking University Third Hospital
name: Inner Mongolia Maternal and Child Health Care Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: Obstetrics & Gynecology Hospital of Fudan University
name: The First Affiliated Hospital of Zhengzhou University
name: Guangdong Women and Children Hospital
name: Guangxi Maternal and Child Health Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Sichuan Provincial People's Hospital
name: Guiyang Maternity and Child Health Care Hospital
First posted: 2013-01-09
Enrollment: 19601
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term or late-preterm newborn infants from thirteen hospital in China were recruited.

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.

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 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.

Primary outcomes:
measure: Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth
timeFrame: Every 12 hr for 168 hr.
Secondary outcomes:
measure: Predictive ability of an hour-specific TcB nomogram
timeFrame: At the 28 days after birth
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Maternal and Children's Hospital, Guangzhou Medical College
state: Guangdong
city: Liuzhou
country: China
facility: Guangxi Maternal and Child Health Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guiyang Maternal and Child Health Hospital
state: Guizhou
city: Harbin
country: China
facility: The First Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Hohhot Shi
country: China
facility: Inner Mongolia Maternal and Child Health Care Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: Jinlin Provincial Maternal and Child Health Hospital
state: Jilin
city: Taiyuan
country: China
facility: Shaanxi Provincial Maternal and Child Health Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial Maternal and Child Health Hospital
state: Shaanxi
city: Chendu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Ürümqi
country: China
facility: The First Hospital of Xinjiang Medical University
state: Xinjiang
city: Beijing
country: China
facility: The Third Hospital of Peking University
city: Shanghai
country: China
facility: Gynecology and Obstetrics Hospital, Fudan University
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Chao Chen, PhD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Shuping Han, PhD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Zhangbin Yu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Harbin Medical University
name: Chunming Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinlin Provincial Maternal and Child Health Hospital
name: Yan Gao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Xiaomei Tong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Meihua Pu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inner Mongolia Maternal and Child Health Care Hospital
name: Hongyun Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Provincial Maternity and Children's Hospital
name: Kezhan Liu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Fudan University
name: Jin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Jimei Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Xiuyong Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Women and Children Hospital
name: Jie Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Maternal and Child Health Hospital
name: Qiufen Wei, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Provincial Maternity and Children's Hospital
name: Zhankui Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Mingxia Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guiyang Maternity and Child Health Care Hospital
name: Ling Liu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Xiaofan Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: