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Search / Trial NCT02082431

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

Launched by PEDIATRIX · Mar 7, 2014

Trial Information

Current as of May 07, 2025

Completed

Keywords

Sensorineural Hearing Loss Long Qt Syndrome

ClinConnect 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.

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 muta...

Gender

ALL

Eligibility criteria

  • 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)

About Pediatrix

Pediatrix is a leading healthcare organization dedicated to improving the health and well-being of infants, children, and expectant mothers through innovative clinical research and high-quality medical care. With a focus on pediatric specialty services, Pediatrix conducts clinical trials to advance the understanding and treatment of various pediatric conditions, ensuring the integration of evidence-based practices into their patient care. Their commitment to pediatric health is reflected in their collaborative approach with healthcare professionals, researchers, and families, aiming to enhance outcomes and provide a brighter future for young patients.

Locations

Rockford, Illinois, United States

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Austin, Texas, United States

Anchorage, Alaska, United States

Waterford, Connecticut, United States

Oklahoma City, Oklahoma, United States

Austin, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Alexandria, Virginia, United States

Fairfax, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Mitchell Cohen, MD

Principal Investigator

Pediatrix

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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