The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
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ClinicalTrials.gov Identifier: NCT00265187 |
Recruitment Status
:
Completed
First Posted
: December 14, 2005
Last Update Posted
: January 3, 2013
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Sponsor:
HaEmek Medical Center, Israel
Information provided by:
HaEmek Medical Center, Israel
Tracking Information | ||||
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First Submitted Date | December 13, 2005 | |||
First Posted Date | December 14, 2005 | |||
Last Update Posted Date | January 3, 2013 | |||
Study Start Date | December 2005 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00265187 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis. | |||
Official Title | 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 | Observational | |||
Study Design | 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 |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment |
200 | |||
Original Enrollment | Same as current | |||
Actual Study Completion Date | March 2006 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | 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 | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00265187 | |||
Other Study ID Numbers | 3350105 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Dan Miron, MD, HaEmek Medical Center, Afula, Israel | |||
Study Sponsor | HaEmek Medical Center, Israel | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | HaEmek Medical Center, Israel | |||
Verification Date | August 2006 |