Long QT and Hearing Loss Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Mednax Center for Research, Education and Quality
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier:
NCT02082431
First received: March 6, 2014
Last updated: June 23, 2016
Last verified: June 2016
  Purpose
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.

Condition
Sensorineural Hearing Loss
Long QT Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long QT & Hearing Loss Prospective Study Registry

Resource links provided by NLM:


Further study details as provided by Mednax Center for Research, Education and Quality:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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?
  Eligibility

Ages Eligible for Study:   up to 90 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newborn infants
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082431

Contacts
Contact: Amy Kelleher, MSHS 800-243-3839 amy_kelleher@pediatrix.com

Locations
United States, Alaska
Jack Jacob Recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Banner Good Samaritan Hospital Recruiting
Phoenix, Arizona, United States, 85006
Contact: Gregory Martin, MD       Gregory_Martin@pediatrix.com   
Principal Investigator: Gregory Martin, MD         
St. Joseph's Hospital & Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Kartik Mody, MD         
United States, Connecticut
Lawrence and Memorial Hospital Recruiting
Waterford, Connecticut, United States, 06320
Contact: Patricia Lake, AuD       plake@lmhosp.org   
Principal Investigator: Patricia lake, AuD         
United States, Illinois
Swedish American Hospital Recruiting
Rockford, Illinois, United States, 61104
Contact: Martin Anyebuno, MD       Martin_Anyebuno@pediatrix.com   
Principal Investigator: Martin Anyebuno, MD         
United States, Virginia
Alexandria Hospital- Inova Health System Recruiting
Alexandria, Virginia, United States, 22304
Contact: Michael Holliday, MD       Michael_Holliday@pediatrix.com   
Principal Investigator: Michael Holliday, MD         
Pediatrix Audiology Services Recruiting
Fairfax, Virginia, United States, 22031
Contact: Jill Young, AuD       jill_young@pediatrix.com   
Sponsors and Collaborators
Mednax Center for Research, Education and Quality
Investigators
Principal Investigator: Mitchell Cohen, MD Mednax Center for Research, Education and Quality
  More Information

Responsible Party: Mednax Center for Research, Education and Quality
ClinicalTrials.gov Identifier: NCT02082431     History of Changes
Other Study ID Numbers: PDX-001-13 
Study First Received: March 6, 2014
Last Updated: June 23, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mednax Center for Research, Education and Quality:
Sensorineural hearing loss
Long QT Syndrome

Additional relevant MeSH terms:
Long QT Syndrome
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2016