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

Recruiting

• Conditions: Hyperbilirubinemia, Neonatal

• Registration Number: NCT06645158
• Lead Sponsor: Neonatal-Infant Brain and Behavior Development Network

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160000

Inclusion Criteria

Gestational age >=35wk; did not admitted to hospital for any reason Less than 30 days of age

Exclusion Criteria

Accept phototherapy within 60h of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of age	through study completion, an average of 1 year	From birth to 7 days of age, newborns should undergo transcutaneous bilirubin monitoring twice daily. From 8 to 14 days of age, jaundice should be monitored once daily, and from 14 to 30 days of age, monitoring should be done at least once every two days.

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center,; 🇨🇳 Guangzhou, Guangdong, China