NCT01763632

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19,601 (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 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.

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DEVICE	Transcutaneous bilirubinometry	Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-01-09
• Last updated: 2014-10-28

Locations

16 sites across 1 country: China