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

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762189
• Other study ID #: NMU-FY2012-319
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: October 25, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Neonatal hyperbilirubinemia resulting in clinical jaundice is a common problem among infants, particularly during the first weeks of life.

Information about the incidence and risk factors of neonatal jaundice is not available from China where is one of the highest countries of the incidence of severe neonatal hyperbilirubinemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13157
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

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.

Locations

Country	Name	City	State
China	The Third Hospital of Peking University	Beijing
China	Jinlin Provincial Maternal and Child Health Hospital	Changchun	Jilin
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Guangdong Maternal and Children's Hospital, Guangzhou Medical College	Guangzhou	Guangdong
China	Guiyang Maternal and Child Health Hospital	Guiyang	Guizhou
China	The First Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Inner Mongolia Maternal and Child Health Care Hospital	Hohhot Shi	Inner Mongolia
China	Guangxi Maternal and Child Health Hospital	Liuzhou	Guangxi
China	Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Children's Hospital of Fudan University	Shanghai
China	Gynecology and Obstetrics Hospital, Fudan University	Shanghai
China	Shaanxi Provincial Maternal and Child Health Hospital	Taiyuan	Shaanxi
China	The First Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (15)

Lead Sponsor

Collaborator

Nanjing Medical University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of participants with risk factors associated with severe neonatal hyperbilirubinemia	The risk factors recognized to be associated with significant hyperbilirubinemia in newborns have included gestational age, weight for Gestational Age, delivery mode, gender, previous infant had phototherapy, bruising/cephalahematoma, feeding mode, excessive body weight loss, and early discharge, et al.	At the 28 days after birth	No