NCT01762189

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,157 (actual)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
PROCEDURE	Phototherapy	The decision to use phototherapy conformed to the hour-specific threshold value for phototherapy presented by the American Academy of Pediatrics guidelines and was not at the discretion of the investigators.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-01-07
• Last updated: 2014-10-28

Locations

14 sites across 1 country: China