Trial record 9 of 23 for:    "Romano-Ward syndrome" OR "Long QT Syndrome"

Long QT and Hearing Loss Registry

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Pediatrix Medical Group
Sponsor:
Collaborator:
MEDNAX Center for Research, Education and Quality
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT02082431
First received: March 6, 2014
Last updated: March 7, 2014
Last verified: March 2014
  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 Pediatrix Medical Group:

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: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (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
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 Not yet recruiting
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Pediatrix Medical Group
MEDNAX Center for Research, Education and Quality
Investigators
Principal Investigator: Mitchell Cohen, MD Pediatrix Medical Group
  More Information

No publications provided

Responsible Party: Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT02082431     History of Changes
Other Study ID Numbers: PDX-001-13
Study First Received: March 6, 2014
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:
Sensorineural hearing loss
Long QT Syndrome

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

ClinicalTrials.gov processed this record on October 22, 2014