Skip to main content
OpenTrials
Completed

NCT Number: NCT06645158

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperbilirubinemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center,

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous bilirubin level monitoring

Device

self-monitoring by parents long-term: from birth to 30 days of age

Primary outcomes

  1. Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of age

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Neonatal-Infant Brain and Behavior Development Network

Network

Collaborators

  • Guangzhou Women and Children's Medical Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.