Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082431
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Tracking Information
First Submitted Date March 6, 2014
First Posted Date March 10, 2014
Last Update Posted Date October 5, 2020
Study Start Date August 2014
Actual Primary Completion Date February 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2019)
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
Original Primary Outcome Measures
 (submitted: March 7, 2014)
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 ]
Change History
Current Secondary Outcome Measures
 (submitted: August 12, 2019)
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
Original Secondary Outcome Measures
 (submitted: March 7, 2014)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.
Official Title Long QT & Hearing Loss Prospective Study Registry
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Newborn infants
Condition
  • Sensorineural Hearing Loss
  • Long QT Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: March 7, 2014)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date July 20, 2020
Actual Primary Completion Date February 18, 2020   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 90 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02082431
Other Study ID Numbers PDX-001-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mednax Center for Research, Education, Quality and Safety
Study Sponsor Mednax Center for Research, Education, Quality and Safety
Collaborators Not Provided
Investigators
Principal Investigator: Mitchell Cohen, MD Mednax Center for Research, Education, Quality and Safety
PRS Account Mednax Center for Research, Education, Quality and Safety
Verification Date October 2020