The Genetics of Respiratory Failure in Bronchiolitis
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Purpose
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.
| Condition |
|---|
|
Bronchiolitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Genetics of Respiratory Failure in Bronchiolitis |
- The primary end point is respiratory failure. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 146 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Cases
Children hospitalized in the ICU with bronchiolitis
|
|
Controls
Children hospitalized in the general ward with bronchiolitis
|
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Children hospitalized with bronchiolitis
Inclusion Criteria, cases:
- admission to the ICU with a primary diagnosis of bronchiolitis
- endotracheally intubated and mechanically ventilated with respiratory failure due to bronchiolitis
- age less than 2 years
Exclusion Criteria, cases:
pre-existing chronic disease including:
- bronchopulmonary dysplasia
- congenital heart disease
- immune deficiency
- requiring an additional venopuncture for blood collection for genotyping
Inclusion Criteria, controls:
- admission to the hospital with a primary diagnosis of bronchiolitis
- age less than 2 years
Exclusion Criteria, controls:
pre-existing chronic disease including:
- bronchopulmonary dysplasia
- congenital heart disease
- immune deficiency
- requiring an additional venopuncture for blood collection for genotyping
- requiring non-invasive positive pressure ventilation or high flow nasal cannula
- requiring intubation and mechanical ventilation during the hospitalization
Contacts and Locations| Contact: Christopher L Carroll, MD, MS | 860-545-9805 | ccarrol@ccmckids.org |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Christopher L Carroll, MD, MS 860-545-9805 ccarrol@ccmckids.org | |
| Principal Investigator: | Christopher L Carroll, MD, MS | Connecticut Children's Medical Center |
More Information
No publications provided
| Responsible Party: | Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center |
| ClinicalTrials.gov Identifier: | NCT01271491 History of Changes |
| Other Study ID Numbers: | 10-097 |
| Study First Received: | November 9, 2010 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Connecticut Children's Medical Center:
|
Pediatric |
Additional relevant MeSH terms:
|
Bronchiolitis Respiratory Insufficiency Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Respiration Disorders |
ClinicalTrials.gov processed this record on May 23, 2013