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

NCT06645158 | Completed DMC

• 1 other identifier: Multi-TCB
• Study Type: observational
• Target: 220,950
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia; transcutaneous bilirubin; neonate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Transcutaneous bilirubin level monitoring DEVICE

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

normal neonate

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

healthy neonates from participating hospitals from 26 provinces in China

You may qualify if:

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

You may not qualify if:

• Accept phototherapy within 60h of age

Sponsors & Collaborators

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

Study Sites (1)

Guangzhou Women and Children's Medical Center,

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: August 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CN (1)