The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01223638
First received: October 3, 2010
Last updated: October 18, 2010
Last verified: October 2010

October 3, 2010
October 18, 2010
September 2010
December 2012   (final data collection date for primary outcome measure)
Hearing Level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01223638 on ClinicalTrials.gov Archive Site
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The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

  • Congenital Hypothyroidism
  • Hearing Loss
Other: Audiometry
Audiometry
  • Congenital hypothyroidism
    Patient which were diagnosed with congenital hypothyroidism
    Intervention: Other: Audiometry
  • Controls
    Patients without any endocrine or hearing problems
    Intervention: Other: Audiometry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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December 2012   (final data collection date for primary outcome measure)

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
Both
2 Years to 30 Years
Yes
Contact: Yardena Rakover - Tenenbaum, M.D. 972-4-6494116 rakover_y@clalit.org.il
Contact: Nirit Vardi, M.A. 972-4-6495368 nirit_va@clalit.org.il
Israel
 
NCT01223638
0128-08-EMC
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Dr. Yardena Tenenbaum - Rakover, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
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HaEmek Medical Center, Israel
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP