The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

NCT01762189 | Completed DMC

• 1 other identifier: NMU-FY2012-319
• Study Type: observational
• Target: 13,157
• Locations: 1 country
• Sites: 14

Brief Summary

Thirteen 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.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia; Neonatal; Incidence; Risk factors

Outcome Measures

Primary Outcomes (1)

• The incidence of severe neonatal hyperbilirubinemia

  Significant hyperbilirubinemia was defined as any TSB level that exceeded the hour-specific threshold value for phototherapy, according to the guidelines presented by the American Academy of Pediatrics.

  At the 28 days after birth

Secondary Outcomes (1)

• Number of participants with risk factors associated with severe neonatal hyperbilirubinemia

  At the 28 days after birth

Interventions

Phototherapy PROCEDURE

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.

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 Seventeen hospitals 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
• 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
• Guangdong Women and Children Hospital: collaborator
• Guangxi Maternal and Child Health Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Guiyang Maternity and Child Health Care Hospital: collaborator

Study Sites (14)

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

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, 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

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

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

• Changhui Chen, PhD

  Sichuan Provincial People's Hospital

  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 7, 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 (14)