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

Sensorineural Hearing Loss Clinical Trial

Official title:

Long QT & Hearing Loss Prospective Study Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082431
• Other study ID #: PDX-001-13
• Status: Completed
• Start date: August 2014
• Est. completion date: July 20, 2020

Study information

• Verified date: October 2020
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 20, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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)

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Long QT Syndrome
• Sensorineural Hearing Loss

Locations

Country	Name	City	State
United States	Alexandria Hospital- Inova Health System	Alexandria	Virginia
United States	Jack Jacob	Anchorage	Alaska
United States	Child Cardiology Associates	Austin	Texas
United States	Dell Children's Medical Center	Austin	Texas
United States	Pediatrix Audiology Services	Fairfax	Virginia
United States	Hearts for Hearing	Oklahoma City	Oklahoma
United States	Banner Good Samaritan Hospital	Phoenix	Arizona
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Swedish American Hospital	Rockford	Illinois
United States	Children's Hospital of San Antonio	San Antonio	Texas
United States	Christus Santa Rosa Westover Hills	San Antonio	Texas
United States	Lawrence and Memorial Hospital	Waterford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	One year