Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.
- Conditions
- Long QT SyndromeSensorineural Hearing Loss
- Registration Number
- NCT02082431
- Lead Sponsor
- Pediatrix
- Brief Summary
The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss.
- Detailed Description
The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss.
The goal of this study is to answer the following questions:
1. What is the incidence of an abnormal ECG (QTc \> 450 msec) in neonates greater than a week of age with either unilateral or bilateral Sensorineural hearing loss?
2. What percentage of neonates greater than one week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG have an identifiable genetic mutation?
3. What is the incidence of an abnormal genetic mutation consistent with long QT regardless of the ECG in neonates with bilateral sensorineural hearing loss?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- All newborns who demonstrate a refer in one or both ears on a routine newborn hearing screen
- Documentation of informed consent
- Inborn
- Ability to perform an ABR (auditory brainstem response screen technology) screening test
- No major anomalies
- Subjects' parents willing to provide follow-up data on their child
- Newborns with a syndromic cause of hearing loss
- Parents unwilling to provide follow-up data
- Major congenital anomalies
- Major medical problem or conditions. (i.e., hypoxic ischemic encephalopathy (HIE), persistent pulmonary hypertension neonate (PPHN), meconium aspiration, etc.)
- Congenital cytomegalovirus (CMV)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss 6 months ECG results to determine QTc length
- Secondary Outcome Measures
Name Time Method In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation One year Audiology diagnostic results
Trial Locations
- Locations (12)
Jack Jacob
🇺🇸Anchorage, Alaska, United States
Banner Good Samaritan Hospital
🇺🇸Phoenix, Arizona, United States
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Lawrence and Memorial Hospital
🇺🇸Waterford, Connecticut, United States
Swedish American Hospital
🇺🇸Rockford, Illinois, United States
Hearts for Hearing
🇺🇸Oklahoma City, Oklahoma, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Child Cardiology Associates
🇺🇸Austin, Texas, United States
Christus Santa Rosa Westover Hills
🇺🇸San Antonio, Texas, United States
Children's Hospital of San Antonio
🇺🇸San Antonio, Texas, United States
Scroll for more (2 remaining)Jack Jacob🇺🇸Anchorage, Alaska, United States