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

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 Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Device: Transcutaneous bilirubin level monitoring

• Study Type: Observational
• Enrollment (Actual): 220950

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Women and Children's Medical Center,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

healthy neonates from participating hospitals from 26 provinces in China

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal neonate; gestational age >= 35wk; did not admitted to hospital for any reason; did not need phototherapy within 60h after birth;	Device: Transcutaneous bilirubin level monitoring; self-monitoring by parents long-term: from birth to 30 days of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Neonatal-Infant Brain and Behavior Development Network
• Collaborators: Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: neonate; Hyperbilirubinemia; transcutaneous bilirubin
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Bilirubin
• Other Study ID Numbers: Multi-TCB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No