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

Long QT & Hearing Loss Prospective Study Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02082431

Enrollment

600

Registered

2014-03-10

Start date

2014-08-31

Completion date

2020-07-20

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long QT Syndrome, Sensorineural Hearing Loss

Keywords

Sensorineural hearing loss, Long QT Syndrome

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?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 90 Days

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss	6 months	ECG results to determine QTc length

Secondary

Measure	Time frame	Description
In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation	One year	Audiology diagnostic results

Countries

United States

Outcome results