Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763632
• Other study ID #: NMU-FY2012-318
• 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19601
• 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

Device:
• Transcutaneous bilirubinometry
Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)

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	Chendu	Sichuan
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	Shaanxi Provincial Maternal and Child Health Hospital	Xi'an	Shaanxi
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	Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth	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.	Every 12 hr for 168 hr.	No
Secondary	Predictive ability of an hour-specific TcB nomogram	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.	At the 28 days after birth	Yes