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

October 1, 2020 updated by: Pediatrix

Long QT & Hearing Loss Prospective Study Registry

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Jack Jacob
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital & Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Hospital
    • Connecticut
      • Waterford, Connecticut, United States, 06320
        • Lawrence and Memorial Hospital
    • Illinois
      • Rockford, Illinois, United States, 61104
        • Swedish American Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Hearts for Hearing
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center
      • Austin, Texas, United States, 78756
        • Child Cardiology Associates
      • San Antonio, Texas, United States, 78251
        • Christus Santa Rosa Westover Hills
      • San Antonio, Texas, United States, 8207
        • Children's Hospital of San Antonio
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Alexandria Hospital- Inova Health System
      • Fairfax, Virginia, United States, 22031
        • Pediatrix Audiology Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborn infants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ECG results to determine QTc length
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Audiology diagnostic results
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Investigators

  • Principal Investigator: Mitchell Cohen, MD, Pediatrix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 18, 2020

Study Completion (Actual)

July 20, 2020

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX-001-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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