Clinical Trial: Long QT and Hearing Loss Registry
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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 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.
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?
Sponsor: Mednax Center for Research, Education and Quality
Current 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 [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current 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 [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Mednax Center for Research, Education and Quality
Dates:
Date Received: March 6, 2014
Date Started: August 2014
Date Completion: April 2018
Last Updated: December 16, 2016
Last Verified: December 2016
