Genetic Testing in Detection of Late-Onset Hearing Loss
Completed
Conditions studied: Hearing Loss, Late-Onset Hearing Loss, Deafness
In brief
Two major limitations of existing audiometric newborn hearing screening programs are their inability to detect forms of deafness that are not expressed at birth and the low compliance with obtaining recommended audiologic confirmation and/or follow-up. Molecular genetic tests on blood spots from all newborns will identify those at risk for the most frequent causes of late-onset hearing loss and to add these infants to the group who should receive continued audiologic monitoring.
Key facts
- Study ID
- NCT00511381
- Run by
- Pediatrix
- People needed
- 3681
- Starts
- 2007-10-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2012-03-01
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Documentation of informed consent
- Inborn
- Ability to do ABR (auditory brainstem response screen technology) screening test on all participants
- Age at enrollment less than 14 days or less than or equal to 336 hours (Birth date is day 0)
- Gestational age > = 34 0/7 weeks and above. (Late preterm infants and term infants)
- No major anomalies
- Ability to obtain blood sample prior to administration of any blood product transfusion
- Subjects' parents or legal guardian willing to provide follow-up data on their child. They will need to provide a telephone contact number and address for follow-up procedures
You may not qualify if…
- Older than 14 days of age or 336 hours
- Receipt of a blood product prior to the ability to obtain blood sample for genetic testing (SoundGene panel)
- Any major congenital anomalies. (chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia, or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)
Where it is running
- Stormont-Vail HealthCare — Topeka, Kansas, United States
- Miami Valley Hospital — Dayton, Ohio, United States
- Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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