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The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
This study has been completed.
Sponsor:
HaEmek Medical Center, Israel
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00265187
First received: December 13, 2005
Last updated: January 2, 2013
Last verified: August 2006
| Tracking Information | ||||
|---|---|---|---|---|
| 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. | |||
| 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. | |||
| 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 | |||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | 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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| Sex/Gender |
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| Ages | up to 2 Years (Child) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Israel | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00265187 | |||
| Other Study ID Numbers ICMJE | 3350105 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| 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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| PRS Account | 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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