Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186349
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-13
Brief Title:
The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMOGVONHB
Brief Summary:
Neonatal hyperbilirubinemia NHB has many causes and is difficult to diagnose and genetic factors play an important role in the metabolism of bilirubin However there is no literature report on the correlation between jaundice gene polymorphism and clinical manifestation polymorphism in big data population This project intends to conduct a prospective observational study led by the Department of Pediatrics of the Sixth Affiliated Hospital of Sun Yat-sen University and in conjunction with a multi-center cooperative hospital 1 A total of 2000 NHB neonatal dry blood spot samples were included for 24 genetic screening tests for 29 NHB-related genetic diseases The construction of the gene database was completed and the carrying and pathogenicity of NHB-related genes in the population was analyzed to provide a scientific basis for the selection of mutation sites for large-scale NHB gene screening 2 Collect neonatal clinical data and percutaneous bilirubin levels through the hospital inpatient system and the percutaneous jaundice meter home monitoring software doctor-patient interconnection method complete the construction of the intelligent NHB clinical database and analyze the impact of jaundice-related genes on NHB 3 Integrated analysis to understand the differences in the carrying rate of pathogenic genes in different degrees and special types of jaundice and to explore the differences in the degree of jaundice carrying single or multiple jaundice pathogenic genes This study will evaluate the feasibility of jaundice gene screening program in the detection of jaundice-related inherited metabolic diseases and provide a basis for early treatment and prevention of NHB
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 RECIRBs
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
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 RECIRBs
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None