Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China
This study is enrolling participants by invitation only.
Sponsor:
Nanjing Medical University
Collaborators:
Children's Hospital of Fudan University
Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
The First Hospital of Harbin Medical University
First Hospital of Jilin University
Peking University Third Hospital
Inner Mongolia Maternal and Child Health Care Hospital
Shaanxi Provincial Maternal and Child Health Hospital
Maternity Hospital of Fudan University
The First Affiliated Hospital of Zhengzhou University
Xiangya Hospital of Central South University
Guangdong Provincial Maternal and Child Health Hospital
Guangxi Maternal and Child Health Hospital
Shaanxi Maternal and Child Health Hospital
The First Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Kunming Medical University
Guiyang Maternal and Child Health Hospital
Information provided by (Responsible Party):
Zhangbin Yu, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01763632
First received: January 2, 2013
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
Seventeen 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.
| Condition | Intervention |
|---|---|
|
Hyperbilirubinemia, Neonatal |
Device: Transcutaneous bilirubinometry |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China |
Resource links provided by NLM:
Further study details as provided by Nanjing Medical University:
Primary Outcome Measures:
- Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth [ Time Frame: Every 12 hr for 168 hr. ] [ Designated as safety issue: No ]During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.
Secondary Outcome Measures:
- Predictive ability of an hour-specific TcB nomogram [ Time Frame: At the 28 days after birth ] [ Designated as safety issue: Yes ]Evaluate the rate of rise of bilirubin for different time periods and percentile curves and to assess predictive ability of these percentile curves for hyperbilirubinemia, defined as requirement of phototherapy.
| Estimated Enrollment: | 14000 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: Transcutaneous bilirubinometry
Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)
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| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Term or late-preterm newborn infants from Seventeen hospital in China were recruited.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763632
Locations
| China, Guangdong | |
| Guangdong Provincial Maternal and Child Health Hospital | |
| Guangzhou, Guangdong, China, 510010 | |
| China, Guangxi | |
| Guangxi Maternal and Child Health Hospital | |
| Liuzhou, Guangxi, China, 530003 | |
| China, Guizhou | |
| Guiyang Maternal and Child Health Hospital | |
| Guiyang, Guizhou, China, 550003 | |
| China, Heilongjiang | |
| The First Hospital of Harbin Medical University | |
| Harbin, Heilongjiang, China, 150001 | |
| China, Henan | |
| The First Affiliated Hospital of Zhengzhou University | |
| Zhengzhou, Henan, China, 410100 | |
| China, Hunan | |
| Xiangya Hospital of Central South University | |
| Changsha, Hunan, China, 410008 | |
| China, Inner Mongolia | |
| Inner Mongolia Maternal and Child Health Care Hospital | |
| Hohhot Shi, Inner Mongolia, China, 010020 | |
| China, Jiangsu | |
| Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University | |
| Nanjing, Jiangsu, China, 210004 | |
| China, Jilin | |
| The First Hospital of Jilin University | |
| Changchun, Jilin, China, 130021 | |
| China, Shaanxi | |
| Shaanxi Provincial Maternal and Child Health Hospital | |
| Taiyuan, Shaanxi, China, 300013 | |
| Shaanxi Maternal and Child Health Hospital | |
| Xi'an, Shaanxi, China, 710003 | |
| China, Sichuan | |
| Sichuan Provincial People's Hospital | |
| Chengdu, Sichuan, China, 610072 | |
| China, Xinjiang | |
| The First Hospital of Xinjiang Medical University | |
| Ürümqi, Xinjiang, China, 830054 | |
| China, Yunnan | |
| The First Affiliated Hospital of Kunming Medical University | |
| Kunming, Yunnan, China, 650032 | |
| China | |
| The Third Hospital of Peking University | |
| Beijing, China, 100191 | |
| Maternity Hospital of Fudan University | |
| Shanghai, China, 200011 | |
| Children's Hospital of Fudan University | |
| Shanghai, China, 200032 | |
Sponsors and Collaborators
Nanjing Medical University
Children's Hospital of Fudan University
Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University
The First Hospital of Harbin Medical University
First Hospital of Jilin University
Peking University Third Hospital
Inner Mongolia Maternal and Child Health Care Hospital
Shaanxi Provincial Maternal and Child Health Hospital
Maternity Hospital of Fudan University
The First Affiliated Hospital of Zhengzhou University
Xiangya Hospital of Central South University
Guangdong Provincial Maternal and Child Health Hospital
Guangxi Maternal and Child Health Hospital
Shaanxi Maternal and Child Health Hospital
The First Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Kunming Medical University
Guiyang Maternal and Child Health Hospital
Investigators
| Study Director: | Chao Chen, PhD | Children's Hospital of Fudan University |
| Study Director: | Shuping Han, PhD | Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University |
| Principal Investigator: | Zhangbin Yu, PhD | Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University |
| Principal Investigator: | Chunming Jiang, PhD | The First Hospital of Harbin Medical University |
| Principal Investigator: | Chaoying Yan, PhD | First Hospital of Jilin University |
| 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 | Shaanxi Provincial Maternal and Child Health Hospital |
| Principal Investigator: | Jin Wang, PhD | Children's Hospital of Fudan University |
| Principal Investigator: | Jimei Wang, PhD | Maternity Hospital of Fudan University |
| Principal Investigator: | Xiuyong Cheng, PhD | The First Affiliated Hospital of Zhengzhou University |
| Principal Investigator: | Shaojie Yue, PhD | Xiangya Hospital of Central South University |
| Principal Investigator: | Jie Yang, PhD | Guangdong Provincial Maternal and Child Health Hospital |
| Principal Investigator: | Qiufen Wei, PhD | Guangxi Maternal and Child Health Hospital |
| Principal Investigator: | Zhankui Li, PhD | Shaanxi Maternal and Child Health Hospital |
| Principal Investigator: | Mingxia Li, PhD | The First Hospital of Xinjiang Medical University |
| Principal Investigator: | Changhui Chen, PhD | Sichuan Provincial People's Hospital |
| Principal Investigator: | Kun Liang, PhD | The First Affiliated Hospital of Kunming Medical University |
| Principal Investigator: | Ling Liu, PhD | Guiyang Maternal and Child Health Hospital |
| Principal Investigator: | Xiaofan Sun, MD | Nanjing Maternity and Child Health Care Hospital of Nanjing Medical University |
More Information
No publications provided
| Responsible Party: | Zhangbin Yu, Principal Investigator, Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT01763632 History of Changes |
| Other Study ID Numbers: | NMU-FY2012-318 |
| Study First Received: | January 2, 2013 |
| Last Updated: | January 4, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Nanjing Medical University:
|
Hyperbilirubinemia Neonatal Transcutaneous Bilirubin |
Additional relevant MeSH terms:
|
Hyperbilirubinemia Hyperbilirubinemia, Neonatal Pathologic Processes Infant, Newborn, Diseases Bilirubin |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013