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The Genetics of Respiratory Failure in Bronchiolitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UConn Health
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT01271491
First received: November 9, 2010
Last updated: January 31, 2017
Last verified: January 2017
  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 ]

Biospecimen Retention:   Samples With DNA
Saliva and blood

Enrollment: 174
Study Start Date: November 2010
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: April 2018 (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

Detailed Description:

We propose to conduct a prospective observational study of infants and children admitted with bronchiolitis to determine if genetic polymorphisms in a number of likely candidate immune response related genes are positively associated with respiratory failure in this population. Respiratory failure will be defined as requiring intubation and mechanical ventilation. We plan to enroll two groups of children, those admitted to the ICU with respiratory failure due to bronchiolitis (cases) and those children admitted to the ward with less severe bronchiolitis infection (controls). In special circumstances, we will also enroll pairs of twins who are hospitalized with bronchiolitis (in the ICU or the ward), for whom either one or both twins do not meet inclusion criteria as a case or a control and/or for whom we are not able to obtain a DNA blood sample while hospitalized (twin inpatient population).

Demographic data, and data regarding the hospital treatments and course of these children will be collected. Blood, saliva or sputum for genotyping will also be obtained. If a patient enrolled as a control needs to be intubated, these children cannot be control patients, but instead would be considered cases.

We propose to compare a population of 100 children with respiratory failure due to bronchiolitis to a population of 100 children with bronchiolitis without respiratory failure. Clinical characteristics and genetic markers will be compared. We will also compare clinical characteristics and genetic markers of any twin pairs who are enrolled.

  Eligibility

Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
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

Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
UConn Health
Investigators
Principal Investigator: Christopher L Carroll, MD, MS Connecticut Children's Medical Center
  More Information

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: January 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Connecticut Children's Medical Center:
Pediatric

Additional relevant MeSH terms:
Respiratory Insufficiency
Bronchiolitis
Respiration Disorders
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on March 23, 2017