Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.
NCT ID: NCT02082431
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2014-08-31
2020-07-20
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
1 Day
90 Days
ALL
Yes
Sponsors
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Pediatrix
OTHER
Responsible Party
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Principal Investigators
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Mitchell Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatrix
Locations
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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
Alexandria Hospital- Inova Health System
Alexandria, Virginia, United States
Pediatrix Audiology Services
Fairfax, Virginia, United States
Countries
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References
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Fenrich AL, Shmorhun DP, Martin GC, Young JA, Cohen MI, Kelleher AS, Anyebuno MA, Rider ED, Motta CL, Clark RH. Long QT and Hearing Loss in High-Risk Infants Prospective Study Registry. Pediatr Cardiol. 2022 Dec;43(8):1898-1902. doi: 10.1007/s00246-022-02939-4. Epub 2022 Jun 3.
Other Identifiers
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PDX-001-13
Identifier Type: -
Identifier Source: org_study_id
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