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

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

Official Title: Multicenter Prospective Study on the Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Brief Summary:

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 Summary:

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.


Sponsor: Nanjing Medical University

Current Primary Outcome: The incidence of severe neonatal hyperbilirubinemia [ Time Frame: At the 28 days after birth ]

Significant hyperbilirubinemia was defined as any TSB level that exceeded the hour-specific threshold value for phototherapy, according to the guidelines presented by the American Academy of Pediatrics.


Original Primary Outcome: The incidence of severe neonatal hyperbilirubinemia [ Time Frame: At the 28 days after birth ]

Significant hyperbilirubinemia was defined as TSB above the 95th percentile for age (high-risk zone) according to the hour-specific percentile nomogram presented by the American Academy of Pediatrics.


Current Secondary Outcome: Number of participants with risk factors associated with severe neonatal hyperbilirubinemia [ Time Frame: At the 28 days after birth ]

The risk factors recognized to be associated with significant hyperbilirubinemia in newborns have included gestational age, weight for Gestational Age, delivery mode, gender, previous infant had phototherapy, bruising/cephalahematoma, feeding mode, excessive body weight loss, and early discharge, et al.


Original Secondary Outcome: Number of participants with risk factors associated with severe neonatal hyperbilirubinemia [ Time Frame: At the 28 days after birth ]

The risk factors recognized to be associated with severe hyperbilirubinemia in newborns have included jaundice in the first 24 hr of life, jaundice noted before discharge from hospital, a sibling who had jaundice treated with phototherapy, late-preterm gestational age of 35-36 weeks, the presence of infant bruising or cephalhematoma, rhesus and ABO incompatibility, et al.


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