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

Completed

• Conditions: Long QT Syndrome; Sensorineural Hearing Loss

• Registration Number: NCT02082431
• Lead Sponsor: Pediatrix

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 Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-10
• Study Start: 2014-08
• Primary Completion: 2020-02-18
• Study Completion: 2020-07-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss	6 months	ECG results to determine QTc length

Secondary Outcome Measures

Name	Time	Method
In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation	One year	Audiology diagnostic results

Trial Locations

Locations (12)

Jack Jacob; 🇺🇸 Anchorage, Alaska, United States

Swedish American Hospital; 🇺🇸 Rockford, Illinois, United States

Child Cardiology Associates; 🇺🇸 Austin, Texas, United States

Alexandria Hospital- Inova Health System; 🇺🇸 Alexandria, Virginia, United States

Lawrence and Memorial Hospital; 🇺🇸 Waterford, Connecticut, United States

Dell Children's Medical Center; 🇺🇸 Austin, Texas, United States

Banner Good Samaritan Hospital; 🇺🇸 Phoenix, Arizona, United States

Christus Santa Rosa Westover Hills; 🇺🇸 San Antonio, Texas, United States

Children's Hospital of San Antonio; 🇺🇸 San Antonio, Texas, United States

Pediatrix Audiology Services; 🇺🇸 Fairfax, Virginia, United States

St. Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

Hearts for Hearing; 🇺🇸 Oklahoma City, Oklahoma, United States