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

Neonatal-Infant Brain and Behavior Development Network220,950 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

220,950

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Transcutaneous bilirubin level monitoringDEVICE

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

Eligibility

Sex: ALLMin age: 0 DaysMax age: 30 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Guangzhou Women and Children's Medical Center,

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

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.

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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