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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
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Study Description
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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.

Condition or disease
Sensorineural Hearing Loss Long QT Syndrome

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?
Study Design
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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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Study Population
Newborn infants
Criteria

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)
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
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Principal Investigator: Mitchell Cohen, MD Mednax Center for Research, Education, Quality and Safety
More Information
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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
Keywords provided by Mednax Center for Research, Education, Quality and Safety:
Sensorineural hearing loss
Long QT Syndrome
Additional relevant MeSH terms:
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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