NCT06645158

TCB Self-Monitoring in Healthy Term and Near-Term Neonates

Self-Monitoring of Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates: a Multi-center Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220,950 (actual)
• Sponsor: Neonatal-Infant Brain and Behavior Development Network · Network
• Sex: All
• Age: 0 Days – 30 Days
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to monitor the transcutaneous bilirubin (TCB) level in healthy near-term and full-term neonates from birth to 30 days of age across China. The main question it aims to answer is: Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants Compare the changing trend of TCB among different areas in China Compare the changing trend of TCB among different gestational groups in China

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DEVICE	Transcutaneous bilirubin level monitoring	self-monitoring by parents long-term: from birth to 30 days of age

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-12-31
• Completion: 2025-07-01
• First posted: 2024-10-16
• Last updated: 2025-09-11

Locations

1 site across 1 country: China