Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome
This study has been completed.
Sponsor:
Pontificia Universidade Catolica de Sao Paulo
Information provided by:
Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00784173
First received: October 31, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 31, 2008 | ||||
| Last Updated Date | October 31, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome | ||||
| Official Title ICMJE | Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children with velocardiofacial syndrome |
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| Condition ICMJE | Ear Malformations in the Velocardiofacial Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00784173 | ||||
| Other Study ID Numbers ICMJE | Unique protocol | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alfredo Tabith Junior, Pontificia Universidade Catolica de São Paulo | ||||
| Study Sponsor ICMJE | Pontificia Universidade Catolica de Sao Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pontificia Universidade Catolica de Sao Paulo | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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