Ear Malformations in the Velocardiofacial SyndromeNCT00784173
Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome
An observational study of Ear Malformations in the Velocardiofacial Syndrome, run by Pontificia Universidade Catolica de Sao Paulo.
Trial summary
Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Ear Malformations in the Velocardiofacial Syndrome
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jun 2007
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children with velocardiofacial syndrome
Who may be able to join
- Subjects with velocardiofacial syndrome
Who cannot join
None listed.
About this study
Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes.
Read the detailed description
Two boys with clinical signs of velocardiofacial syndrome, at ages of 4.7 and 6,7 years old are the subjects of this study.Audiological evaluation, including pure tone audiometry, tympanometry, acoustical reflex, and Computerized Tomography of temporal bones, and analyses of DNA sample with markers of 22q11 region were performed.
- Keywords
- Syndrome, Velocardiofacial, Middle ear, Inner ear, Malformation
- Medical subject headings
- Syndrome, Congenital Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear Malformations in the Velocardiofacial SyndromeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Catolica de Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Alfredo Tabith-Junior, MD, Principal investigator, Pontificia Universidade Católica de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784173
- Sponsor's protocol ID
- Unique protocol
- Status last verified
- Oct 2008
- First submitted
- 31 Oct 2008
- Last updated
- 3 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome
- ClinicalTrials.gov ID
- NCT00784173
- Acronym / sponsor ID
- Unique protocol
- Keywords
- Syndrome, Velocardiofacial, Middle ear, Inner ear, Malformation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Pontificia Universidade Catolica de Sao PauloUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Nov 2008 (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.
Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes.
Detailed description
Two boys with clinical signs of velocardiofacial syndrome, at ages of 4.7 and 6,7 years old are the subjects of this study.Audiological evaluation, including pure tone audiometry, tympanometry, acoustical reflex, and Computerized Tomography of temporal bones, and analyses of DNA sample with markers of 22q11 region were performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with velocardiofacial syndrome
Key inclusion criteria (1 listed)
- Subjects with velocardiofacial syndrome
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2008.
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.
Alfredo Tabith-Junior, MD principal investigator
Pontificia Universidade Católica de São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Ear Malformations in the Velocardiofacial Syndrome, run by Pontificia Universidade Catolica de Sao Paulo.
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 0 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: finished, as of the sponsor's last update on 3 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Nov 2008.