- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06186349
The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia (EMOGVONHB)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adverse reactions: In this study, only 3 drops of neonatal heel peripheral blood were collected for genetic analysis and statistical analysis of percutaneous jaundice values. No human trials were involved. Family members were willing to know the genetic test results and the genetic test results were positive. Family members may have a certain psychological burden. We will provide free professional genetic counseling, as detailed as possible to inform the hazards of this genetic defect, treatment and other related information to help. Psychiatrists can be arranged for free psychological counseling if necessary.
Ethical approval: This clinical study follows the Helsinki Declaration ( 2013 edition ), the ethical principles of human medical research and the relevant clinical research norms and regulations in China.
This clinical study was approved by the Research Ethics Committee / Institutional Review Boards ( REC/IRBs ).
This clinical study is an observational clinical study initiated by researchers. The clinical research protocol ( including informed consent and case report forms, etc. ) and other information provided to the family members or guardians of the newborn were reviewed and approved by the ethics committee of the clinical research team leader unit and the participating units.
Informed consent: Before the start of the clinical study, the researchers completely and comprehensively introduced the purpose, process, method, and the interests and risks of the newborn to the parents or legal representatives who met the inclusion criteria. A written informed consent form was given to each parent or guardian of the newborn before enrollment, so that he / she had sufficient time to consider whether to consent to the collection of neonatal information to participate in this clinical study. After obtaining the informed consent of each newborn 's parent or legal representative and signing the informed consent form, researchers can begin to collect relevant data.
Privacy protection: All members of the research team, including the primary researchers and their authorized researchers, must comply with all local and regional regulatory requirements and applicable privacy regulations.
Each newborn participating in this study will be assigned a unique number and an institutional identifier.
All research data will be stored in a confidential electronic system and stored for at least 3 years after the completion of the study.
The coding table for recording neonatal information and research will be kept by the researcher (PI) in a locked file cabinet or in a password-protected database. Only researchers and their authorized researchers have the right to access the coding table.
The coding table that records the name of the hospital and the institution identification number will be saved by the research team in a locked file cabinet, which is only limited to access by limited research members. The identity of each subject of observation should be kept confidential in research reports and related publications.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hu Hao
- Phone Number: 86-020-38777850
- Email: haohu@mail.sysu.edu.cn
Study Contact Backup
- Name: Wenna Lin
- Phone Number: 86-020-38777850
- Email: linwn5@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510655
- Recruiting
- the Sixth Affiliated Hospital, Sun Yat-sen University
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Contact:
- Hu Hao
- Phone Number: 86-020-38777850
- Email: haohu@mail.sysu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 1-28 days
- gestational age ≥ 35 weeks
- Birth weight ≥ 2.5 kg and < 4 kg.
Exclusion Criteria:
- Neonatal data with unclear clinical basic information ;
- Lack of traceability core information data ;
- data that the test results cannot be analyzed and interpreted ;
- Sample collection is not qualified and unwilling to cooperate with re-sampling.
- Newborns with severe deformity and severe lethal inherited metabolic diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
non-significant hyperbilirubinemia
including 500 cases of non-significant hyperbilirubinemia ( TSB / TCB < 205umol / L )
|
Newborns with neonatal hyperbilirubinemia who did not randomly receive genome sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
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significant hyperbilirubinemia
500 cases of significant hyperbilirubinemia ( 205umol / L ≤ TSB / TCB < 342umol / L )
|
Newborns with neonatal hyperbilirubinemia who did not randomly receive genome sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
|
severe hyperbilirubinemia
500 cases of severe hyperbilirubinemia ( TSB / TCB ≥ 342umol / L )
|
Newborns with neonatal hyperbilirubinemia who did not randomly receive genome sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
|
Extremely severe hyperbilirubinemia
500 cases ( TSB / TCB ≥ 428umol / L )
|
Newborns with neonatal hyperbilirubinemia who did not randomly receive genome sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of gene sequencing data in neonatal gene bank
Time Frame: From birth to completion of genetic screening, the process last up to 3 months.
|
Each newborn that was sequenced was counted as 1.
Keep all the data in the gene bank, and finally calculate the number of completed gene sequencing data.
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From birth to completion of genetic screening, the process last up to 3 months.
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Gene mutation rate
Time Frame: From birth to completion of genetic screening, the process last up to 3 months.
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Taking the number of newborn babies as denominator and the number of neonates with gene mutation detected in gene sequencing as molecules, the whole neonatal gene mutation rate in China was obtained.
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From birth to completion of genetic screening, the process last up to 3 months.
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carrying rate of pathogenic genes
Time Frame: From birth to completion of genetic screening, the process last up to 3 months.
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the carrying rate of pathogenic genes of common hereditary jaundice diseases in newborns was counted
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From birth to completion of genetic screening, the process last up to 3 months.
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phenotypic polymorphism
Time Frame: From birth to completion of genetic screening, the process last up to 3 months.
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analyze the correlation between gene polymorphism and clinical manifestations ( phenotypic polymorphism ) of neonatal hyperbilirubinemia.
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From birth to completion of genetic screening, the process last up to 3 months.
|
Collaborators and Investigators
Investigators
- Study Director: Hu Hao, Department of Pediatrics, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Publications and helpful links
General Publications
- Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.
- Olusanya BO, Kaplan M, Hansen TWR. Neonatal hyperbilirubinaemia: a global perspective. Lancet Child Adolesc Health. 2018 Aug;2(8):610-620. doi: 10.1016/S2352-4642(18)30139-1. Epub 2018 Jun 28.
- Watchko JF, Lin Z. Exploring the genetic architecture of neonatal hyperbilirubinemia. Semin Fetal Neonatal Med. 2010 Jun;15(3):169-75. doi: 10.1016/j.siny.2009.11.003. Epub 2009 Dec 21.
- Yang H, Wang Q, Zheng L, Zheng XB, Lin M, Zhan XF, Yang LY. Clinical Significance of UGT1A1 Genetic Analysis in Chinese Neonates with Severe Hyperbilirubinemia. Pediatr Neonatol. 2016 Aug;57(4):310-7. doi: 10.1016/j.pedneo.2015.08.008. Epub 2015 Dec 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMGVNHB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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