Brief Title
Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.
Official Title
Long QT & Hearing Loss Prospective Study Registry
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?
Study Type
Observational
Primary Outcome
The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss
Secondary Outcome
In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation
Condition
Sensorineural Hearing Loss
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
600
Start Date
August 2014
Completion Date
July 20, 2020
Primary Completion Date
February 18, 2020
Eligibility 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)
Gender
All
Ages
1 Day - 90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Mitchell Cohen, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02082431
Organization ID
PDX-001-13
Responsible Party
Sponsor
Study Sponsor
Mednax Center for Research, Education, Quality and Safety
Study Sponsor
Mitchell Cohen, MD, Principal Investigator, Mednax Center for Research, Education, Quality and Safety
Verification Date
October 2020