- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805165
Hour-specific Transcutaneous Bilirubin in Healthy Term and Near-term Newborns of China
January 14, 2019 updated by: yangjie, Guangdong Women and Children Hospital
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.
Study Overview
Status
Unknown
Conditions
Detailed Description
Jaundice in common amount Chinese newborn population.
The neonatal jaundice guildline was made base on the AAP.
guideline.
Chinese newborn have their jaundice follow up and treatment plans make base on American neonatel jaundice data.
Our group are now planning to have our own neonatel jaundice data by joinning the major neonate centers all around China.
A neonatal jaundiced nomogram would be made base on Chinese neonatel jaundice data.
Study Type
Observational
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 511442
- Jie Yang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 week (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Term and near term newborns, whos gestational age was more than 35 weeks(≥35)
Description
Inclusion Criteria:
gestational age more than 35 weeks(≥35) -
Exclusion Criteria:
all kinds of congenital diseases, infants with pathologic jaundice
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hour-specific Transcutaneous Bilirubin Level
Time Frame: 1 year
|
make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 1, 2019
Primary Completion (ANTICIPATED)
March 31, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
December 25, 2018
First Submitted That Met QC Criteria
January 14, 2019
First Posted (ACTUAL)
January 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Guangdong WCH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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