The Genetics of Respiratory Failure in Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Connecticut Children's Medical Center
Sponsor:
Collaborator:
University of Connecticut Health Center
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT01271491
First received: November 9, 2010
Last updated: February 12, 2013
Last verified: February 2013

November 9, 2010
February 12, 2013
November 2010
April 2015   (final data collection date for primary outcome measure)
The primary end point is respiratory failure. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01271491 on ClinicalTrials.gov Archive Site
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The Genetics of Respiratory Failure in Bronchiolitis
The Genetics of Respiratory Failure in Bronchiolitis

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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Children hospitalized with bronchiolitis

Bronchiolitis
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  • Cases
    Children hospitalized in the ICU with bronchiolitis
  • Controls
    Children hospitalized in the general ward with bronchiolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
146
October 2015
April 2015   (final data collection date for primary outcome measure)

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:

    1. bronchopulmonary dysplasia
    2. congenital heart disease
    3. 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:

    1. bronchopulmonary dysplasia
    2. congenital heart disease
    3. 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
Both
up to 2 Years
No
Contact: Christopher L Carroll, MD, MS 860-545-9805 ccarrol@ccmckids.org
United States
 
NCT01271491
10-097
No
Christopher Carroll, MD, Connecticut Children's Medical Center
Connecticut Children's Medical Center
University of Connecticut Health Center
Principal Investigator: Christopher L Carroll, MD, MS Connecticut Children's Medical Center
Connecticut Children's Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP