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The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
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Started Sep 2010
Longer than P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 3, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 8, 2015
July 1, 2015
2.3 years
October 3, 2010
July 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hearing Level
2 years
Study Arms (2)
Congenital hypothyroidism
Patient which were diagnosed with congenital hypothyroidism
Controls
Patients without any endocrine or hearing problems
Interventions
Eligibility Criteria
Patients aged 2-30 years with congenital hypothyroidism which are being followed at the Pediatric Endocrine Department at Ha'Emek Medical Center.
You may qualify if:
- Patients with congenital hypothyroidism aged 2-30 years
You may not qualify if:
- Hearing defects in the family
- Intrauterine infections
- Perinatal hypoxia
- Long term therapy with aminoglycosides
- Acoustic trauma in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ha'Emek Medical Center
Afula, 18101, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 3, 2010
First Posted
October 19, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2012
Study Completion
June 1, 2015
Last Updated
July 8, 2015
Record last verified: 2015-07