The Genetics of Respiratory Failure in Bronchiolitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01271491|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2011
Last Update Posted : February 2, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||174 participants|
|Official Title:||The Genetics of Respiratory Failure in Bronchiolitis|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2018|
Children hospitalized in the ICU with bronchiolitis
Children hospitalized in the general ward with bronchiolitis
- The primary end point is respiratory failure. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271491
|United States, Connecticut|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|Principal Investigator:||Christopher L Carroll, MD, MS||Connecticut Children's Medical Center|