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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02453750 |
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Date of registration:
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21/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Airway Inflammation in Congenital Diaphragmatic Hernia Patients
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Scientific title:
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Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02453750 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Theo Moraes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 6 - 18 years of age at enrolment
- Clinically stable at enrolment
- Attending follow-up in the CDH Clinic at SickKids
Exclusion Criteria:
- Unable to perform pulmonary function testing
- Clinically unstable at enrolment
- Known hypersensitivity to salbutamol
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Congenital Diaphragmatic Hernia
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Intervention(s)
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Drug: Hypersaline
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Drug: Bronchodilator Response
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Primary Outcome(s)
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Number of Participants With Elevated Sputum Eosinophils
[Time Frame: post sputum induction]
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Secondary Outcome(s)
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Number of Participant With Bronchodilator Response
[Time Frame: life time of child (age 6 to present age)]
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Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level
[Time Frame: 30 min]
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Number of Participant With Elevated Sputum Neutrophils
[Time Frame: Baseline, +30 minutes]
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Secondary ID(s)
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1000028032
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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