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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypersaline and Bronchodilator Response | Experimental | After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypersaline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Elevated Sputum Eosinophils | Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum | post sputum induction |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant With Elevated Sputum Neutrophils | Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation | Baseline, +30 minutes |
| Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theo Moraes, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypersaline and Bronchodilator Response | Each child will perform a sputum induction to obtain cells for analysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 to obtain cells for analysis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Elevated Sputum Eosinophils | Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum | 15 gave reasonable sputum for analysis, none had elevated sputum eosinophils | Posted | Number | participants | post sputum induction |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Theo Moraes | SickKids | 416 813 2196 | theo.moraes@sickkids.ca |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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|
| Bronchodilator Response | Drug | 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. |
|
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
| 30 min |
| Number of Participant With Bronchodilator Response | defined as a = or > 12% change in FEV1 post bronchodilator | life time of child (age 6 to present age) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Number of Participant With Elevated Sputum Neutrophils | Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation | 15 gave reasonable sputum | Posted | Number | participants | Baseline, +30 minutes |
|
|
|
| Secondary | Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level | 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 | only 12 performed eNO | Posted | Count of Participants | Participants | 30 min |
|
|
|
| Secondary | Number of Participant With Bronchodilator Response | defined as a = or > 12% change in FEV1 post bronchodilator | all subjects performed PFTs | Posted | Number | participants | life time of child (age 6 to present age) |
|
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |