Airway Inflammation in Congenital Diaphragmatic Hernia Patients
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|ClinicalTrials.gov Identifier: NCT02453750|
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Diaphragmatic Hernia||Drug: Hypersaline Drug: Bronchodilator Response||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Hypersaline and Bronchodilator Response
After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
Subject will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. Sputum production (with cough) will be attempted post inhalation. A maximum of 3 hypertonic saline inhalations will be attempted if inhalation does not generate a productive cough. If sputum induction is not successful and the FEV1 falls <10%, the concentration of inhaled hypertonic saline will increase from 3 to 4%. If 5 mls of 4% hypertonic saline inhaled for 7 minutes does not produce a productive cough we will proceed to 5%. If 5 mls of 5% hypertonic saline inhaled for 7 minutes does not produce a productive cough the test is complete and the sample is labelled 'no sputum collected'. If FEV1 falls >10%, the previous step will be repeated.
Drug: Bronchodilator Response
A bronchodilator (Salbutamol 200 mcg or 2 puffs inhaled via spacer device) will be administered to all subjects in the pulmonary function laboratory. 15 minutes after administration of the bronchodilator spirometry will be repeated. This is performed routinely in CDH clinic and is not an additional test for this study.
- Number of Participants With Elevated Sputum Eosinophils [ Time Frame: post sputum induction ]Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum
- Number of Participant With Elevated Sputum Neutrophils [ Time Frame: Baseline, +30 minutes ]Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation
- Number of Participant With Elevated 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.
greater than 20 ppb was considered elevated
- Number of Participant With Bronchodilator Response [ Time Frame: life time of child (age 6 to present age) ]defined as a = or > 12% change in FEV1 post bronchodilator
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): NCT02453750
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Theo Moraes, MD||The Hospital for Sick Children|