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Clinical Trials/NCT06365749
NCT06365749
Not yet recruiting
Not Applicable

Exome Sequencing Explored the Genetic Characteristics Congenital Hearing Loss in Chinese Population

Dan Bing0 sites50 target enrollmentApril 23, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Hearing Loss
Sponsor
Dan Bing
Enrollment
50
Primary Endpoint
Whole exome sequencing data
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:

  • to present the genetic characteristics of the infant with hearing loss in the Chinese population
  • to build up a prognostic model base on diverse data.

Participants will be asked to receive audiological tests and collection of the peripheral blood sample.

Registry
clinicaltrials.gov
Start Date
April 23, 2024
End Date
November 23, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dan Bing
Responsible Party
Sponsor Investigator
Principal Investigator

Dan Bing

associate professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Age up to 6 months
  • Fail in the neonatal hearing screening programs, including oto-acoustic emissions and automated auditory brain stem response
  • Promise to complete the tests required at baseline and follow-ups by the legal representative
  • Informed consent by the legal representative

Exclusion Criteria

  • Congenital infections related to acquired or congenital hearing loss, including rubella virus, cytomegalovirus, herpes simplex virus, rubella virus, toxoplasma gondii and treponema pallidum infections
  • Other explicit otologic conditions which could induce hearing loss, including cerumen, otitis media, congenital middle ear abnormalities, microtia and external ear abnormalities
  • A drug with ototoxicity usage during pregnancy
  • Other severe congenital anomalies

Outcomes

Primary Outcomes

Whole exome sequencing data

Time Frame: Baseline

DNA of neonate extracted from blood sample by heel prick or collection of cord blood will be perform whole exome sequencing to present genetic features. By sequencing all protein-coding regions, WES uncovers mutations that can inform diagnostic, therapeutic, and preventive strategies. Key outcome measures from WES include the detection of single nucleotide polymorphisms, insertions, deletions, and structural variants. These outcomes are critical for diagnosing genetic disorders, personalizing treatments, and assessing disease risk. The analysis involves aligning reads to a reference genome, calling variants, and interpreting their clinical significance. WES data thus serves as a cornerstone in genetic research and personalized medicine, enabling a deeper understanding of the genetic underpinnings of diseases and tailoring healthcare approaches to individual genetic profiles.

Secondary Outcomes

  • Auditory brainstem response testing(Baseline)
  • TEOAE-based otoacoustic emissions test outcome measure(Baseline)
  • Acoustic impedance(Baseline)
  • Audiogram(4 years follow up)

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