The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
| Tracking Information | |||||
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| First Received Date ICMJE | December 13, 2005 | ||||
| Last Updated Date | January 2, 2013 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00265187 on ClinicalTrials.gov Archive Site | ||||
| 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 | The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis. | ||||
| Official Title ICMJE | The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis in Northern Israel. | ||||
| Brief Summary | Sputum specimens will be obtained from children < 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained. |
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| Detailed Description | The purpose of the study is to asses the various pathogens of bronchiolitis in children and its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel. Included will be about 200 infants and children < 2 years hospitalized with bronchiolitis. From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis - PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA. Epidemiological data will be obtained for every child by structured questioner. Clinical data will be daily obtained by scoring system. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children 0-24 months hospitalized with acute bronchiolitis |
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| Condition ICMJE |
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| 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 | 200 | ||||
| Completion Date | March 2006 | ||||
| Primary Completion Date | March 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Age 0-24 months, hospitalized children, - Exclusion Criteria:Previous hospitalization, previous RSV immunization, immunocompromised patient, previous inclusion in this study, inclusion in another study. - |
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| Gender | Both | ||||
| Ages | up to 2 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00265187 | ||||
| Other Study ID Numbers ICMJE | 3350105 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dan Miron, MD, HaEmek Medical Center, Afula, Israel | ||||
| Study Sponsor ICMJE | HaEmek Medical Center, Israel | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | HaEmek Medical Center, Israel | ||||
| Verification Date | August 2006 | ||||
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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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