The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia
NCT ID: NCT06186349
Last Updated: 2024-01-02
Study Results
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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RECRUITING
2000 participants
OBSERVATIONAL
2023-09-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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non-significant hyperbilirubinemia
including 500 cases of non-significant hyperbilirubinemia ( TSB / TCB \< 205umol / L )
Genomic sequencing
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.
significant hyperbilirubinemia
500 cases of significant hyperbilirubinemia ( 205umol / L ≤ TSB / TCB \< 342umol / L )
Genomic sequencing
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 )
Genomic sequencing
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 )
Genomic sequencing
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.
Interventions
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Genomic sequencing
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.
Eligibility Criteria
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Inclusion Criteria
* gestational age ≥ 35 weeks
* Birth weight ≥ 2.5 kg and \< 4 kg.
Exclusion Criteria
* 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
1 Day
28 Days
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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HaoHu
Project leader
Principal Investigators
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Hu Hao
Role: STUDY_DIRECTOR
Department of Pediatrics, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Locations
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The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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EMGVNHB
Identifier Type: -
Identifier Source: org_study_id
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