Trial record 1 of 1 for:
NCT02082431
Long QT and Hearing Loss Registry
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| ClinicalTrials.gov Identifier: NCT02082431 |
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Recruitment Status :
Recruiting
First Posted : March 10, 2014
Last Update Posted : February 1, 2018
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Sponsor:
Mednax Center for Research, Education, Quality and Safety
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety
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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 |
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 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Andersen-Tawil syndrome
Jervell and Lange-Nielsen syndrome
Romano-Ward syndrome
Nonsyndromic hearing loss
MedlinePlus related topics:
Hearing Disorders and Deafness
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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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)
Information from the National Library of Medicine
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
Contacts
| Contact: Amy Kelleher, MSHS | 800-243-3839 | amy_kelleher@pediatrix.com |
Locations
| United States, Alaska | |
| Jack Jacob | Completed |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Banner Good Samaritan Hospital | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Gregory Martin, MD Gregory_Martin@pediatrix.com | |
| Principal Investigator: Gregory Martin, MD | |
| St. Joseph's Hospital & Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Kartik Mody, MD | |
| United States, Connecticut | |
| Lawrence and Memorial Hospital | Recruiting |
| Waterford, Connecticut, United States, 06320 | |
| Contact: Patricia Lake, AuD plake@lmhosp.org | |
| Principal Investigator: Patricia lake, AuD | |
| United States, Florida | |
| Osceola Regional Medical Center | Completed |
| Kissimmee, Florida, United States, 34741 | |
| United States, Illinois | |
| Swedish American Hospital | Completed |
| Rockford, Illinois, United States, 61104 | |
| United States, Oklahoma | |
| Hearts for Hearing | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Principal Investigator: Sara Neumann, Au.D. | |
| United States, South Carolina | |
| Lexington Medical Center | Completed |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Dell Children's Medical Center | Completed |
| Austin, Texas, United States, 78723 | |
| Child Cardiology Associates | Recruiting |
| Austin, Texas, United States, 78756 | |
| Principal Investigator: Arnold Fenrich Jr., MD | |
| Christus Santa Rosa Westover Hills | Recruiting |
| San Antonio, Texas, United States, 78251 | |
| Principal Investigator: Katherine Brandt, MD | |
| Children's Hospital of San Antonio | Recruiting |
| San Antonio, Texas, United States, 8207 | |
| Principal Investigator: Cheryl Motta, MD | |
| United States, Virginia | |
| Alexandria Hospital- Inova Health System | Recruiting |
| Alexandria, Virginia, United States, 22304 | |
| Contact: Michael Holliday, MD Michael_Holliday@pediatrix.com | |
| Principal Investigator: Michael Holliday, MD | |
| Pediatrix Audiology Services | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Jill Young, AuD jill_young@pediatrix.com | |
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
| 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 History of Changes |
| Other Study ID Numbers: |
PDX-001-13 |
| First Posted: | March 10, 2014 Key Record Dates |
| Last Update Posted: | February 1, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Mednax Center for Research, Education, Quality and Safety:
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Sensorineural hearing loss Long QT Syndrome |
Additional relevant MeSH terms:
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Hearing Loss Deafness Hearing Loss, Sensorineural Long QT Syndrome Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Pathologic Processes |