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

Completed

• Conditions: Hyperbilirubinemia, Neonatal

• Registration Number: NCT01763632
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-09
• 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: 19601

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
Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth	Every 12 hr for 168 hr.	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

Name	Time	Method
Predictive ability of an hour-specific TcB nomogram	At the 28 days after birth	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.

Trial Locations

Locations (14)

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

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

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

Shaanxi Provincial Maternal and Child Health Hospital; 🇨🇳 Xi'an, Shaanxi, China

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

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