The Genetics of Respiratory Failure in Bronchiolitis

NCT01271491 | Completed

• 1 other identifier: 10-097
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• Respiratory Failure

  The primary end point is respiratory failure.

  2 years

Study Arms (2)

Cases

Children hospitalized in the ICU with bronchiolitis

Controls

Children hospitalized in the general ward with bronchiolitis

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children hospitalized with bronchiolitis

You may qualify if:

• 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

You may not qualify if:

• pre-existing chronic disease including:
• bronchopulmonary dysplasia
• congenital heart disease
• immune deficiency
• requiring an additional venopuncture for blood collection for genotyping
• admission to the hospital with a primary diagnosis of bronchiolitis
• age less than 2 years
• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• UConn Health: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Christopher L Carroll, MD, MS

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: January 6, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)