NCT02082431

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

Long QT & Hearing Loss Prospective Study Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Pediatrix · Academic / Other
• Sex: All
• Age: 1 Day – 90 Days
• Healthy volunteers: Accepted

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?

Conditions

• Sensorineural Hearing Loss
• Long QT Syndrome

Timeline

• Start date: 2014-08-01
• Primary completion: 2020-02-18
• Completion: 2020-07-20
• First posted: 2014-03-10
• Last updated: 2020-10-05

Locations

12 sites across 1 country: United States