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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: Nanjing Medical University

Current Primary Outcome: 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. ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Predictive ability of an hour-specific TcB nomogram [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Nanjing Medical University

Dates:
Date Received: January 2, 2013
Date Started: January 2013
Date Completion:
Last Updated: October 25, 2014
Last Verified: October 2014