Clinical Trial: Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Brief Summary: We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway inflammation as a first step to characterize the reported bronchodilator responsiveness. Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to document the amount and type of inflammation present. Another ancillary non-invasive measure of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective of this study is to determine if CDH patients have any evidence of airway inflammation. The hypothesis of this study is that children with CDH do not have evidence of airway inflammation associated with bronchodilator responsiveness. Based on this information, treatment for CDH patients will hopefully be more accurate and appropriate for their specific needs.

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Sputum Eosinophil Counts [ Time Frame: Baseline, +30 minutes ]

Children will be divided by sputum eosinophils into 2 groups:

  • or = 3% eosinophils = eosinophilic inflammation

    • < 3% eosinophils = no inflammation

The mean, standard deviation (SD) and coefficient of variation (CV, calculated as 100 x SD/mean) will be calculated for each group. The proportion of children with CDH that have eosinophilic inflammation will be determined.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sputum Neutrophil Counts [ Time Frame: Baseline, +30 minutes ]

    Children will be divided by sputum neutrophils into 2 groups

    • > or = 61% neutrophils = neutrophilic inflammation
    • < 3% neutrophils = no inflammation
  • Exhaled Nitric Oxide (NO) Level [ Time Frame: 30 min ]
    exhaled NO measurements will be performed according to the American Thoracic Society and European Respiratory Society guidelines. These tests are performed routinely as part of the respiratory evaluation of these patients and are not additional tests added for this study.
  • Correlation of sputum counts and exhaled nitric oxide with bronchodilator response [ Time Frame: 0 min ]

    All patients will be divided into 2 groups by bronchodilator response:

    • >12% bronchodilator response: positive BDR
    • <12% bronchodilator response: negative BDR


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: May 21, 2015
Date Started: February 2012
Date Completion:
Last Updated: May 21, 2015
Last Verified: May 2015