NCT02082431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

5.6 years

First QC Date

March 6, 2014

Last Update Submit

October 1, 2020

Conditions

Sensorineural Hearing LossLong QT Syndrome

Keywords

Sensorineural hearing lossLong QT Syndrome

Outcome Measures

Primary Outcomes (1)

  • The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss

    ECG results to determine QTc length

    6 months

Secondary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Day - 90 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn infants

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Jack Jacob

Anchorage, Alaska, 99508, United States

Location

Banner Good Samaritan Hospital

Phoenix, Arizona, 85006, United States

Location

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Lawrence and Memorial Hospital

Waterford, Connecticut, 06320, United States

Location

Swedish American Hospital

Rockford, Illinois, 61104, United States

Location

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

Location

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Child Cardiology Associates

Austin, Texas, 78756, United States

Location

Christus Santa Rosa Westover Hills

San Antonio, Texas, 78251, United States

Location

Children's Hospital of San Antonio

San Antonio, Texas, 8207, United States

Location

Alexandria Hospital- Inova Health System

Alexandria, Virginia, 22304, United States

Location

Pediatrix Audiology Services

Fairfax, Virginia, 22031, United States

Location

Related Publications (1)

  • Fenrich AL, Shmorhun DP, Martin GC, Young JA, Cohen MI, Kelleher AS, Anyebuno MA, Rider ED, Motta CL, Clark RH. Long QT and Hearing Loss in High-Risk Infants Prospective Study Registry. Pediatr Cardiol. 2022 Dec;43(8):1898-1902. doi: 10.1007/s00246-022-02939-4. Epub 2022 Jun 3.

    PMID: 35661239DERIVED

MeSH Terms

Conditions

Hearing Loss, SensorineuralLong QT Syndrome

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic Processes

Study Officials

  • Mitchell Cohen, MD

    Pediatrix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 10, 2014

Study Start

August 1, 2014

Primary Completion

February 18, 2020

Study Completion

July 20, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

US(12)