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

NCT ID: NCT06645158

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Hyperbilirubinemia, Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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normal neonate

gestational age \>= 35wk; did not admitted to hospital for any reason; did not need phototherapy within 60h after birth;

Transcutaneous bilirubin level monitoring

Intervention Type DEVICE

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

Interventions

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Transcutaneous bilirubin level monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Neonatal-Infant Brain and Behavior Development Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangzhou Women and Children's Medical Center,

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Multi-TCB

Identifier Type: -

Identifier Source: org_study_id

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