Genetic Feature of Congenital Hearing Loss in Chinese Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Hearing Loss, Congenital Deafness. Basic parameters: up to 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exome Sequencing Explored the Genetic Characteristics Congenital Hearing Loss in Chinese Population
Overview
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.
Primary outcome measures
- Whole exome sequencing data [Time frame: Baseline]
Secondary outcome measures (4)
- TEOAE-based otoacoustic emissions test outcome measure [Time frame: Baseline]
- Auditory brainstem response testing [Time frame: Baseline]
- Acoustic impedance [Time frame: Baseline]
- Audiogram [Time frame: 4 years follow up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06365749 · TJ-IRB20221228