An observational study in Congenital Hearing Loss and Congenital Deafness, sponsored by Dan Bing. Not yet recruiting. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Dan Bing · Observational
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:
Participants will be asked to receive audiological tests and collection of the peripheral blood sample.
160 studies on the registry are indexed under Deafness; 46 are open to participants now.
This study's planned enrollment of 50 is below the median of 101 across 47 observational studies indexed under Deafness.
Browse Deafness studies →Dan Bing is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Neonates who were offered neonatal hearing screening programs at Tongji hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates who failed in the neonatal hearing screening programs, including oto-acoustic emissions and automated auditory brain stem response.
Whole exome sequencing data
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.
Time frame: Baseline
TEOAE-based otoacoustic emissions test outcome measure
In analyzing Transient Evoked Otoacoustic Emissions (TEOAE), key factors include response reproducibility, which indicates consistent cochlear responses, and signal-to-noise ratio (SNR), where a value above 3 dB suggests clear cochlear emissions against background noise. The Response Spectrum provides a frequency-specific look at cochlear performance, essential for identifying potential hearing issues. A 'Pass' in the TEOAE test denotes normal cochlear function, while a 'Refer' indicates the need for further hearing evaluations.
Time frame: Baseline
Auditory brainstem response testing
In auditory brainstem response (ABR) testing, waveform reproducibility and waveform latency, especially of Wave V, are key. High reproducibility indicates reliable signal transmission, suggesting a healthy auditory system. Appropriate latency for Wave V indicates efficient signal processing. Frequency-Specific Responses highlight the brainstem's reaction across different sound frequencies, aiding in identifying potential issues. 'Normal' ABR results reflect functional auditory pathways, while 'Abnormal' ones prompt further investigation.
Time frame: Baseline
Acoustic impedance
Acoustic impedance, a critical parameter in sound wave dynamics, quantifies a medium's opposition to sound propagation, expressed as the ratio of acoustic pressure to particle velocity. This parameter is shaped by the medium's density and the speed of sound through it, pivotal for understanding sound behavior in various environments. In audiology, specifically in tympanometry, impedance measurements diagnose middle ear conditions by assessing how sound waves are absorbed or reflected, revealing conditions like effusion or tympanic membrane perforations. The results are typically classified into Jerger types, which categorize middle ear function based on the impedance curve's shape and peak characteristics, providing a detailed insight into middle ear health. High impedance may indicate obstructions or stiffness in the middle ear, while low impedance could suggest perforations or discontinuities.
Time frame: Baseline
Audiogram
Pure-tone threshold testing is a cornerstone of audiological assessment, used to determine the softest level at which an individual can hear sounds of specific frequencies. During the test, pure tones of various frequencies are presented through headphones or earphones to one ear at a time, or through a speaker for bone conduction testing. The process begins at an audible level, gradually decreasing until the sound is no longer heard, then slightly increasing until it is heard again. This method helps identify the threshold, or the lowest level at which a sound is perceived 50% of the time for each frequency tested, typically ranging from low (250 Hz) to high (8000 Hz) frequencies.
Time frame: 4 years follow up
No study locations are listed for this record.
Start is estimated for Apr 2024; primary completion for Nov 2026, 31 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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