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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06645158
Enrollment
220950
Registered
2024-10-16
Start date
2020-08-01
Completion date
2025-07-01
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia, transcutaneous bilirubin, neonate

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

Interventions

DEVICETranscutaneous bilirubin level monitoring

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

Sponsors

Guangzhou Women and Children's Medical Center
CollaboratorOTHER
Neonatal-Infant Brain and Behavior Development Network
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 30 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of agethrough study completion, an average of 1 yearFrom 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026