Hearing LossCODESNCT06133946
Cohort Of DEafness-gene Screening
An observational study of Hearing Loss, run by Affiliated Hospital of Nantong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 1 week
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Genetic screening test (Deafness gene variant detection array kit)
- How many people
- 35,920 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: Participants were newborn infants born between January 2016 and December 2020 from the Han population in Nantong city, China.
Who may be able to join
- The infants were born between January 2016 and December 2020;
- The infants' health condition was good enough to tolerate the screening procedures;
- The parents were urban residents of Nantong city;
- The parents agreed to have their babies participating in the combined hearing and genetic screening program.
Who cannot join
- The infants' blood samples were unqualified for the genetic tests according to criteria of the National Health Commission of China's technical specification for neonatal screening of congenital diseases;
- The infants were lost to follow-up.
About this study
Official title: Cohort of Universal Newborn Deafness-gene Screening in Nantong City, China
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.
Read the 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: c.35delG, c.176_191del16, c.235delC, c.299_300delAT (GJB2 gene); c.1174A>T, c.1226G>A, c.1229C>T, c.1975G>C, c.2027T>A, c.2168A>G, c.IVS7-2A>G, c.IVS15 + 5G>A (SLC26A4 gene); m.1494C>T, m.1555A>G (MT-RNR1 gene); c.538C>T (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 infant's parents.
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.
- Conditions
- Hearing Loss
- Being tested
- Genetic screening test (Deafness gene variant detection array kit)
- Keywords
- Newborn hearing screening, Genetic screening, Cohort study
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic screening test (Deafness gene variant detection array kit)Genetic
Also called Newborn hearing screening test (otoacoustic emission, OAE), Hearing re-screening test (OAE and automated auditory brainstem response [AABR]）, Hearing diagnostic test (auditory brainstem response [ABR] and auditory steady state response [ASSR])
Infant participants were screened for fifteen variants in four genes (i.e., GJB2, SLC26A4, MT-RNR1 and GJB3).
| Study group | Role | What they receive |
|---|---|---|
| Combined screening | All newborns underwent combined hearing and genetic screening. Receives: Genetic: Genetic screening test (Deafness gene variant detection array kit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of hearing loss at age of 3 months
Diagnosis of HL was confirmed by hearing diagnostic tests (ABR+ASSR) at age of 3 months.
Auditory steady-state response (ASSR) were used as an alternative and adjunct to the auditory brainstem response (ABR) for threshold estimation.
Measured: From Jan 1, 2016 to Mar 31, 2021
Secondary outcomes (3)
Language ability of HL children at ages of 5 years and 8 years
Mandarin sentence repetition task (MSRT) was used to reflect the children's language ability.
Measured: From Jan 1, 2021 to Dec 31, 2028
Receptive vocabulary of HL children at ages of 5 years and 8 years
The Chinese version of the Peabody Picture Vocabulary Test-Revised (C-PPVT-R, Lu \& Liu, 1998) was used to evaluate children's expressive vocabulary ability. The possible score ranged from 0-125, and test-retest reliability was exceeded 0.9.
Measured: From Jan 1, 2021 to Dec 31, 2028
Non-verbal IQ of HL children at ages of 5 years and 8 years
The Chinese version of the Test of Nonverbal Intelligence, fourth edition (C-TONI-4, Lin et al., 2016) was used to evaluate children's nonverbal intelligence regarding problem solving and abstract reasoning. The possible score ranged from 0 to 48, and internal consistency reliability was 0.87.
Measured: From Jan 1, 2021 to Dec 31, 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2016
- Primary completion31 Mar 2021
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Nantong Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Gang Qin, MD, PhD, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133946
- Sponsor's protocol ID
- BE2015655
- Acronym
- CODES
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Universal Newborn Deafness-gene Screening in Nantong City, China
- ClinicalTrials.gov ID
- NCT06133946
- Acronym / sponsor ID
- CODES / BE2015655
- Conditions
- Hearing Loss
- Keywords
- Newborn hearing screening, Genetic screening, Cohort study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35,920 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- Nantong Maternal and Child Health Care Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: c.35delG, c.176_191del16, c.235delC, c.299_300delAT (GJB2 gene); c.1174A>T, c.1226G>A, c.1229C>T, c.1975G>C, c.2027T>A, c.2168A>G, c.IVS7-2A>G, c.IVS15 + 5G>A (SLC26A4 gene); m.1494C>T, m.1555A>G (MT-RNR1 gene); c.538C>T (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 infant's parents.
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined screening | – | Genetic: Genetic screening test (Deafness gene variant detection array kit)All newborns underwent combined hearing and genetic screening. |
Who may qualify
- Ages
- 3 days to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants were newborn infants born between January 2016 and December 2020 from the Han population in Nantong city, China.
Key inclusion criteria (4 listed)
- The infants were born between January 2016 and December 2020;
- The infants' health condition was good enough to tolerate the screening procedures;
- The parents were urban residents of Nantong city;
- The parents agreed to have their babies participating in the combined hearing and genetic screening program.
Key exclusion criteria (2 listed)
- The infants' blood samples were unqualified for the genetic tests according to criteria of the National Health Commission of China's technical specification for neonatal screening of congenital diseases;
- The infants were lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic screening test (Deafness gene variant detection array kit)Also: Newborn hearing screening test (otoacoustic emission, OAE), Hearing re-screening test (OAE and automated auditory brainstem response [AABR]）, Hearing diagnostic test (auditory brainstem response [ABR] and auditory steady state response [ASSR])Infant participants were screened for fifteen variants in four genes (i.e., GJB2, SLC26A4, MT-RNR1 and GJB3). | Genetic | Combined screening |
Primary outcome
Diagnosis of hearing loss at age of 3 months
Time frame: From Jan 1, 2016 to Mar 31, 2021
Diagnosis of HL was confirmed by hearing diagnostic tests (ABR+ASSR) at age of 3 months. Auditory steady-state response (ASSR) were used as an alternative and adjunct to the auditory brainstem response (ABR) for threshold estimation.
3 secondary outcomes
Language ability of HL children at ages of 5 years and 8 years
Time frame: From Jan 1, 2021 to Dec 31, 2028
Receptive vocabulary of HL children at ages of 5 years and 8 years
Time frame: From Jan 1, 2021 to Dec 31, 2028
Non-verbal IQ of HL children at ages of 5 years and 8 years
Time frame: From Jan 1, 2021 to Dec 31, 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Affiliated Hospital of Nantong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of hearing loss at age of 3 months (time frame: From Jan 1, 2016 to Mar 31, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.