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

NCT ID: NCT01762189

Last Updated: 2014-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

13157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperbilirubinemia, Neonatal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

Nanjing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Jinlin Provincial Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Inner Mongolia Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role collaborator

Guangdong Women and Children Hospital

OTHER

Sponsor Role collaborator

Guangxi Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Guiyang Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhangbin Yu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chao Chen, PhD

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Shuping Han, PhD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Zhangbin Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Maternity and Child Health Care Hospital

Chunming Jiang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Yan Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

Jinlin Provincial Maternal and Child Health Hospital

Xiaomei Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Meihua Pu, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Hongyun Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Inner Mongolia Maternal and Child Health Care Hospital

Kezhan Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanxi Provincial Maternity and Children's Hospital

Jin Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Jimei Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics & Gynecology Hospital of Fudan University

Xiuyong Cheng, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Jie Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Women and Children Hospital

Qiufen Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Maternal and Child Health Hospital

Zhankui Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanxi Provincial Maternity and Children's Hospital

Mingxia Li, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Changhui Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Ling Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Guiyang Maternity and Child Health Care Hospital

Xiaofan Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Maternity and Child Health Care Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Guangdong Maternal and Children's Hospital, Guangzhou Medical College

Guangzhou, Guangdong, China

Site Status

Guangxi Maternal and Child Health Hospital

Liuzhou, Guangxi, China

Site Status

Guiyang Maternal and Child Health Hospital

Guiyang, Guizhou, China

Site Status

The First Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Inner Mongolia Maternal and Child Health Care Hospital

Hohhot, Inner Mongolia, China

Site Status

Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Jinlin Provincial Maternal and Child Health Hospital

Changchun, Jilin, China

Site Status

Shaanxi Provincial Maternal and Child Health Hospital

Taiyuan, Shaanxi, China

Site Status

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

The First Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

The Third Hospital of Peking University

Beijing, , China

Site Status

Gynecology and Obstetrics Hospital, Fudan University

Shanghai, , China

Site Status

Children's Hospital of Fudan University

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NMU-FY2012-319

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyperbilirubinemia in Full-term Neonates
NCT06238349 RECRUITING PHASE4
Transcutaneous Bilirubinometry and Phototherapy
NCT04246229 NOT_YET_RECRUITING NA
Value of Transcutaneous Bilirubin Devices
NCT06232174 NOT_YET_RECRUITING
Cycled Phototherapy
NCT03927833 ACTIVE_NOT_RECRUITING NA