The Genetics of Respiratory Failure in Bronchiolitis
| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2010 | ||||
| Last Updated Date | February 12, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary end point is respiratory failure. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01271491 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 Genetics of Respiratory Failure in Bronchiolitis | ||||
| Official Title ICMJE | The Genetics of Respiratory Failure in Bronchiolitis | ||||
| Brief Summary | Bronchiolitis is a potentially severe infection of the airway in infants and children, and among the most frequent diagnoses leading to pediatric intensive care unit admission in infants. This acute infection is caused by an array of viruses, but respiratory syncytial virus (RSV) is the most frequently implicated. The majority of infants hospitalized with bronchiolitis are previously healthy, and half of infants intubated and mechanically ventilated for respiratory failure due to RSV bronchiolitis have no previously identified risk factors. It is likely, therefore, that other factors, particularly genetic heterogeneity of the host, contribute to disease severity. However, no previous study has investigated the association of genetic variants with respiratory failure in children with bronchiolitis. Several categories of candidate genes have emerged as potentially important in the pathogenesis of the disease. Specifically, genetic polymorphisms of surfactants, pattern recognition receptors, receptor adhesion molecules, and cytokines have been examined. The aim is to evaluate these polymorphisms to determine their association with respiratory failure in a cohort of more severely ill children with bronchiolitis. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Children hospitalized with bronchiolitis |
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| Condition ICMJE | Bronchiolitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 146 | ||||
| Estimated Completion Date | October 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria, cases:
Exclusion Criteria, cases:
Inclusion Criteria, controls:
Exclusion Criteria, controls:
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| Gender | Both | ||||
| Ages | up to 2 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01271491 | ||||
| Other Study ID Numbers ICMJE | 10-097 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christopher Carroll, MD, Connecticut Children's Medical Center | ||||
| Study Sponsor ICMJE | Connecticut Children's Medical Center | ||||
| Collaborators ICMJE | University of Connecticut Health Center | ||||
| Investigators ICMJE |
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| Information Provided By | Connecticut Children's Medical Center | ||||
| Verification Date | February 2013 | ||||
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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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