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
  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

Resource links provided by NLM:


Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • 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
Study Population

Children hospitalized with bronchiolitis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271491

Contacts
Contact: Christopher L Carroll, MD, MS 860-545-9805 ccarrol@ccmckids.org

Locations
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   
Sponsors and Collaborators
Connecticut Children's Medical Center
University of Connecticut Health Center
Investigators
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
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 21, 2014