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

Completed

• Conditions: Hyperbilirubinemia, Neonatal

• Registration Number: NCT01762189
• Lead Sponsor: Nanjing Medical University

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.

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 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-25
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13157

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of severe neonatal hyperbilirubinemia	At the 28 days after birth	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with risk factors associated with severe neonatal hyperbilirubinemia	At the 28 days after birth	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.

Trial Locations

Locations (14)

Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China

Guangdong Maternal and Children's Hospital, Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China

Guangxi Maternal and Child Health Hospital; 🇨🇳 Liuzhou, Guangxi, China

Guiyang Maternal and Child Health Hospital; 🇨🇳 Guiyang, Guizhou, China

The First Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Inner Mongolia Maternal and Child Health Care Hospital; 🇨🇳 Hohhot Shi, Inner Mongolia, China

Jinlin Provincial Maternal and Child Health Hospital; 🇨🇳 Changchun, Jilin, China

Shaanxi Provincial Maternal and Child Health Hospital; 🇨🇳 Taiyuan, Shaanxi, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

The First Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

Gynecology and Obstetrics Hospital, Fudan University; 🇨🇳 Shanghai, China

The Third Hospital of Peking University; 🇨🇳 Beijing, China