Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Cohort of Universal Newborn Deafness-gene Screening in Nantong City, China

ID
Name
BE2015655
Description
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.
Trial arms
Trial start
2016-01-01
Estimated PCD
2021-03-31
Trial end
2028-12-31
Status
Active (not recruiting)
Treatment
Genetic screening test (Deafness gene variant detection array kit)
Infant participants were screened for fifteen variants in four genes (i.e., GJB2, SLC26A4, MT-RNR1 and GJB3).
Arms:
Combined screening
Other names:
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])
Size
35920
Primary endpoint
Diagnosis of hearing loss at age of 3 months
From Jan 1, 2016 to Mar 31, 2021
Eligibility criteria
Inclusion Criteria: 1. The infants were born between January 2016 and December 2020; 2. The infants' health condition was good enough to tolerate the screening procedures; 3. The parents were urban residents of Nantong city; 4. The parents agreed to have their babies participating in the combined hearing and genetic screening program. Exclusion Criteria: 1. 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; 2. The infants were lost to follow-up.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Dried blood spot specimen was collected from the infants' heel sticks. 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)."}, 'enrollmentInfo': {'count': 35920, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

1 product

1 indication

Organization
Affiliated Hospital of Nantong University
Product
Genetic screening test
Indication
Hearing impairment