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

N/ACompletedNCT02082431

Pediatrix600 enrolled

Overview

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 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

Enrollment

600

Conditions

Sensorineural Hearing Loss Long QT Syndrome

Eligibility

Sex: ALLMin age: 1 DayMax age: 90 DaysHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (12)

Jack Jacob

Anchorage, Alaska, United States

Banner Good Samaritan Hospital

Phoenix, Arizona, United States

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss

ECG results to determine QTc length

Time frame: 6 months

Secondary Outcomes

In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation

Audiology diagnostic results

Time frame: One year

Data from ClinicalTrials.gov

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