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Long QT and Hearing Loss Registry

This study is currently recruiting participants.
Verified December 2016 by Mednax Center for Research, Education, Quality and Safety
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082431
First Posted: March 10, 2014
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety
March 6, 2014
March 10, 2014
December 19, 2016
August 2014
December 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02082431 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Not Provided
 
Long QT and Hearing Loss Registry
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.

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?
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Newborn infants
  • Sensorineural Hearing Loss
  • Long QT Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2018
December 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
up to 90 Days   (Child)
Yes
Contact: Amy Kelleher, MSHS 800-243-3839 amy_kelleher@pediatrix.com
United States
 
 
NCT02082431
PDX-001-13
No
Not Provided
Not Provided
Mednax Center for Research, Education, Quality and Safety
Mednax Center for Research, Education, Quality and Safety
Not Provided
Principal Investigator: Mitchell Cohen, MD Mednax Center for Research, Education, Quality and Safety
Mednax Center for Research, Education, Quality and Safety
December 2016