Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.
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ClinicalTrials.gov Identifier: NCT02082431 |
Recruitment Status :
Completed
First Posted : March 10, 2014
Last Update Posted : October 5, 2020
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Condition or disease |
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Sensorineural Hearing Loss Long QT Syndrome |
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:
- 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?
- 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?
- What is the incidence of an abnormal genetic mutation consistent with long QT regardless of the ECG in neonates with bilateral sensorineural hearing loss?
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Long QT & Hearing Loss Prospective Study Registry |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | February 18, 2020 |
Actual Study Completion Date : | July 20, 2020 |

- The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss [ Time Frame: 6 months ]ECG results to determine QTc length
- In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation [ Time Frame: One year ]Audiology diagnostic results

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Ages Eligible for Study: | up to 90 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082431
United States, Alaska | |
Jack Jacob | |
Anchorage, Alaska, United States, 99508 | |
United States, Arizona | |
Banner Good Samaritan Hospital | |
Phoenix, Arizona, United States, 85006 | |
St. Joseph's Hospital & Medical Center | |
Phoenix, Arizona, United States, 85013 | |
United States, Connecticut | |
Lawrence and Memorial Hospital | |
Waterford, Connecticut, United States, 06320 | |
United States, Illinois | |
Swedish American Hospital | |
Rockford, Illinois, United States, 61104 | |
United States, Oklahoma | |
Hearts for Hearing | |
Oklahoma City, Oklahoma, United States, 73120 | |
United States, Texas | |
Dell Children's Medical Center | |
Austin, Texas, United States, 78723 | |
Child Cardiology Associates | |
Austin, Texas, United States, 78756 | |
Christus Santa Rosa Westover Hills | |
San Antonio, Texas, United States, 78251 | |
Children's Hospital of San Antonio | |
San Antonio, Texas, United States, 8207 | |
United States, Virginia | |
Alexandria Hospital- Inova Health System | |
Alexandria, Virginia, United States, 22304 | |
Pediatrix Audiology Services | |
Fairfax, Virginia, United States, 22031 |
Principal Investigator: | Mitchell Cohen, MD | Mednax Center for Research, Education, Quality and Safety |
Responsible Party: | Mednax Center for Research, Education, Quality and Safety |
ClinicalTrials.gov Identifier: | NCT02082431 |
Other Study ID Numbers: |
PDX-001-13 |
First Posted: | March 10, 2014 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
Sensorineural hearing loss Long QT Syndrome |
Hearing Loss Deafness Hearing Loss, Sensorineural Long QT Syndrome Pathologic Processes Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities |