Congenital HypothyroidismNCT01223638
The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
An observational study of Congenital Hypothyroidism and Hearing Loss, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hypothyroidism, Hearing Loss
- What is being tested?
- Audiometry
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients aged 2-30 years with congenital hypothyroidism which are being followed at the Pediatric Endocrine Department at Ha'Emek Medical Center.
Who may be able to join
- Patients with congenital hypothyroidism aged 2-30 years
Who cannot join
- Hearing defects in the family
- Intrauterine infections
- Perinatal hypoxia
- Long term therapy with aminoglycosides
- Acoustic trauma in the past
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Congenital Hypothyroidism, Hearing Loss
- Being tested
- Audiometry
- Keywords
- Congenital hypothyroidism(CH), Hearing loss among children with CH
- Medical subject headings
- Congenital Hypothyroidism, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AudiometryOther
Audiometry
| Study group | Role | What they receive |
|---|---|---|
| Congenital hypothyroidism | Patient which were diagnosed with congenital hypothyroidism Receives: Other: Audiometry | |
| Controls | Patients without any endocrine or hearing problems Receives: Other: Audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionJun 2015
Why it stopped: written here by mistake
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223638
- Sponsor's protocol ID
- 0128-08-EMC
- Status last verified
- Jul 2015
- First submitted
- 3 Oct 2010
- Last updated
- 8 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
- ClinicalTrials.gov ID
- NCT01223638
- Acronym / sponsor ID
- 0128-08-EMC
- Conditions
- Congenital Hypothyroidism, Hearing Loss
- Keywords
- Congenital hypothyroidism(CH), Hearing loss among children with CH
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: written here by mistake
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital hypothyroidism | – | Other: AudiometryPatient which were diagnosed with congenital hypothyroidism |
| Controls | – | Other: AudiometryPatients without any endocrine or hearing problems |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 2-30 years with congenital hypothyroidism which are being followed at the Pediatric Endocrine Department at Ha'Emek Medical Center.
Key inclusion criteria (1 listed)
- Patients with congenital hypothyroidism aged 2-30 years
Key exclusion criteria (5 listed)
- Hearing defects in the family
- Intrauterine infections
- Perinatal hypoxia
- Long term therapy with aminoglycosides
- Acoustic trauma in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AudiometryAudiometry | Other | Congenital hypothyroidism, Controls |
Primary outcome
Hearing Level
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hypothyroidism and Hearing Loss, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Level (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.