The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism

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ClinicalTrials.gov Identifier: NCT01223638

Recruitment Status : Withdrawn (written here by mistake)

First Posted : October 19, 2010

Last Update Posted : July 8, 2015

Sponsor:

Information provided by:

HaEmek Medical Center, Israel

Study Description

Brief Summary:

Congenital hypothyroidism (CH) occurs in 1:4000 live births. Neurological disturbances like speech delay, motor delay and lower IQ were reported in children with CH. Evidence from animal experiments indicate that CH is associated with high frequency of deafness. Morphological changes of the external and internal cholera hairs were reported in mutagenic mice with CH. Anatomical changes of the internal ear and low hearing threshold were reported in mice bearing Dual oxidase 2 (Duox2) gene mutations, which is responsible of oxidation of iodide. Knockout of Pax8 gene in mice resulted in both agenesis of thyroid gland and deafness. Early L-thyroxin therapy prevented the development of deafness in those mice. The expression of thyroid receptor α (TRα) in the external and internal cholera hairs in mice indicates that the thyroid hormones have an important role in the development of the internal ear.

The etiology of deafness in human is both genetic and environmental. The prevalence of deafness in live births is 1:1000 and among them 60% is genetic. Connexin 26 gene mutations are the most common cause of inherited deafness and account for about 40% of the genetic cases. In two conditions in human the coexistence of hypothyroidism and deafness were reported; Pendred syndrome and thyroid hormone resistance syndrome.

The prevalence of hearing loss in human with CH was explored in only few studies and the results are contrary.

The aim of the current study is to study the prevalence of hearing loss among children with CH and to compare the clinical, biochemical and genetic characteristics between subjects with hearing loss to those without hearing loss.

Condition or disease	Intervention/treatment
Congenital Hypothyroidism Hearing Loss	Other: Audiometry

Study Design


Study Type :	Observational
Actual Enrollment :	0 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Study Start Date :	September 2010
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	June 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Congenital hypothyroidism Nonsyndromic hearing loss

MedlinePlus related topics: Hearing Disorders and Deafness Hypothyroidism

Genetic and Rare Diseases Information Center resources: Congenital Hypothyroidism

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Congenital hypothyroidism Patient which were diagnosed with congenital hypothyroidism	Other: Audiometry Audiometry
Controls Patients without any endocrine or hearing problems	Other: Audiometry Audiometry

Outcome Measures

Primary Outcome Measures :

Hearing Level [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years to 30 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients aged 2-30 years with congenital hypothyroidism which are being followed at the Pediatric Endocrine Department at Ha'Emek Medical Center.

Criteria

Inclusion Criteria:

Patients with congenital hypothyroidism aged 2-30 years

Exclusion Criteria:

Hearing defects in the family
Intrauterine infections
Perinatal hypoxia
Long term therapy with aminoglycosides
Acoustic trauma in the past

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223638

Locations


Israel
Ha'Emek Medical Center
Afula, Israel, 18101

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information


Responsible Party:	Dr. Yardena Tenenbaum - Rakover, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT01223638 History of Changes
Other Study ID Numbers:	0128-08-EMC
First Posted:	October 19, 2010 Key Record Dates
Last Update Posted:	July 8, 2015
Last Verified:	July 2015

Keywords provided by HaEmek Medical Center, Israel:


Congenital hypothyroidism(CH) Hearing loss among children with CH

Additional relevant MeSH terms:


Hypothyroidism Congenital Hypothyroidism Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases	Signs and Symptoms Thyroid Diseases Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Genetic Diseases, Inborn

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