Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133946
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-08
Brief Title:
Cohort Of DEafness-gene Screening
Sponsor:
Affiliated Hospital of Nantong University
Organization:
Affiliated Hospital of Nantong University
Study Overview
Official Title:
Cohort of Universal Newborn Deafness-gene Screening in Nantong City China
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
CODES
Brief Summary:
This study was based on a concurrent newborn genetic and hearing screening program in Nantong city From January 2016 to December 2020 newborn infants were recruited and received combined screening for free funded in part by the municipal government and research project foundations The population-based longitudinal databank for all children with hearing loss in Nantong city commenced in January 2016 and maintained indefinite recruitment and ongoing follow-up
Detailed Description:
The severity of hearing loss was graded as mild 26-40 dB moderate 41-60 dB severe 61-80 dB and profound 81 dB
Genomic DNA was extracted by a blood filter paper nucleic acid extraction kit CapitalBio Beijing China and tested using a deafness gene variant detection array kit CapitalBio Beijing China with LuxScan 10K-B Microarray Scanner CapitalBio Beijing China The genetic screening entailed genotyping 15 variants in 4 genes c35delG c176_191del16 c235delC c299_300delAT GJB2 gene c1174AT c1226GA c1229CT c1975GC c2027TA c2168AG cIVS7-2AG cIVS15 5GA SLC26A4 gene m1494CT m1555AG MT-RNR1 gene c538CT GJB3 gene The results were categorized as 1 negative 2 carrier GJB2 or SLC26A4 heterozygous mutations MT-RNR1 mutations GJB3 mutations or heterozygous mutations in multiple genes and 3 refer GJB2 or SLC26A4 homozygous or compound heterozygous mutations
This study was approved by the ethics committees of Nantong municipal Health Commission and all hospitals involved Written informed consent was obtained from the infants parents
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology STROBE reporting guideline for cohort studies
Genomic DNA was extracted by a blood filter paper nucleic acid extraction kit CapitalBio Beijing China and tested using a deafness gene variant detection array kit CapitalBio Beijing China with LuxScan 10K-B Microarray Scanner CapitalBio Beijing China The genetic screening entailed genotyping 15 variants in 4 genes c35delG c176_191del16 c235delC c299_300delAT GJB2 gene c1174AT c1226GA c1229CT c1975GC c2027TA c2168AG cIVS7-2AG cIVS15 5GA SLC26A4 gene m1494CT m1555AG MT-RNR1 gene c538CT GJB3 gene The results were categorized as 1 negative 2 carrier GJB2 or SLC26A4 heterozygous mutations MT-RNR1 mutations GJB3 mutations or heterozygous mutations in multiple genes and 3 refer GJB2 or SLC26A4 homozygous or compound heterozygous mutations
This study was approved by the ethics committees of Nantong municipal Health Commission and all hospitals involved Written informed consent was obtained from the infants parents
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology STROBE reporting guideline for cohort studies
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