Hyperbilirubinemia, NeonatalNCT06645158
TCB Self-Monitoring in Healthy Term and Near-Term Neonates
An observational study of Hyperbilirubinemia, Neonatal, run by Neonatal-Infant Brain and Behavior Development Network at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Transcutaneous bilirubin level monitoring
- Type of treatment
- Medical device
- How many people
- 220,950 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy neonates from participating hospitals from 26 provinces in China
Who may be able to join
- Gestational age >=35wk; did not admitted to hospital for any reason Less than 30 days of age
Who cannot join
- Accept phototherapy within 60h of age
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center,
Guangzhou, Guangdong, 510120
About this study
Official title: 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
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Transcutaneous bilirubin level monitoring
- Keywords
- Hyperbilirubinemia, transcutaneous bilirubin, neonate
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous bilirubin level monitoringDevice
self-monitoring by parents long-term: from birth to 30 days of age
| Study group | Role | What they receive |
|---|---|---|
| normal neonate | gestational age >= 35wk; did not admitted to hospital for any reason; did not need phototherapy within 60h after birth; Receives: Device: Transcutaneous bilirubin level monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Aug 2020
- Primary completion31 Dec 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neonatal-Infant Brain and Behavior Development Network
- Sponsor type
- Research network
- Collaborators
- Guangzhou Women and Children's Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645158
- Sponsor's protocol ID
- Multi-TCB
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring of Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates: a Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT06645158
- Acronym / sponsor ID
- Multi-TCB
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, transcutaneous bilirubin, neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220,950 participants (actual)
- Lead sponsor
- Neonatal-Infant Brain and Behavior Development NetworkResearch network
- Collaborators
- Guangzhou Women and Children's Medical Center
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal neonate | – | Device: Transcutaneous bilirubin level monitoringgestational age >= 35wk; did not admitted to hospital for any reason; did not need phototherapy within 60h after birth; |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy neonates from participating hospitals from 26 provinces in China
Key inclusion criteria (1 listed)
- Gestational age >=35wk; did not admitted to hospital for any reason Less than 30 days of age
Key exclusion criteria (1 listed)
- Accept phototherapy within 60h of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous bilirubin level monitoringself-monitoring by parents long-term: from birth to 30 days of age | Device | normal neonate |
Primary outcome
Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of age
Time frame: through study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal, run by Neonatal-Infant Brain and Behavior Development Network at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of age (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.