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Trial record 3 of 8 for:    "Congenital hypothyroidism"

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
  Purpose

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 Intervention
Congenital Hypothyroidism
Hearing Loss
Other: Audiometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Hearing Level [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Congenital hypothyroidism
Patient which were diagnosed with congenital hypothyroidism
Other: Audiometry
Audiometry
Controls
Patients without any endocrine or hearing problems
Other: Audiometry
Audiometry

  Eligibility

Ages Eligible for Study:   2 Years to 30 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223638

Contacts
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

Locations
Israel
Ha'Emek Medical Center Not yet recruiting
Afula, Israel, 18101
Contact: Yardena Rakover - Tenenbaum, M.D.    972-4-6495203    rakover_y@clalit.org.il   
Principal Investigator: Yardena Rakover - Tenenbaum, M.D.         
Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Nirit Vardi, MsC    97246495368    nirit_va@clalit.org.il   
Principal Investigator: Yardena T Rakover, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Dr. Yardena Tenenbaum - Rakover, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01223638     History of Changes
Other Study ID Numbers: 0128-08-EMC
Study First Received: October 3, 2010
Last Updated: October 18, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by HaEmek Medical Center, Israel:
Congenital hypothyroidism(CH)
Hearing loss among children with CH

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

ClinicalTrials.gov processed this record on November 23, 2014