Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.

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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

December 2019

Primary Completion Date

December 2019

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

N/A - 90 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mitchell Cohen, MD, 800-243-3839, [email protected]

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

August 2019