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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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19 February 2015 |
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Main ID: |
NCT00753987 |
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Date of registration:
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15/09/2008 |
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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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Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis
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Scientific title:
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Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00753987 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Felix Ratjen, MD, FRCP(C) |
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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:
- Confirmed diagnosis of cystic fibrosis
- Age 2 months to 2 years
- Routinely scheduled infant pulmonary function test.
- Clinical stability (no respirator tract infection for 4 weeks prior to study
Exclusion Criteria:
- Acute respiratory symptoms
- Wheezing at the time of study
- Supplemental oxygen therapy
- Oxygen saturation < 95 % on room air
Age minimum:
2 Months
Age maximum:
2 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Hypertonic Saline
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Primary Outcome(s)
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The immediate effect of HS on lung function in infants with CF, as measured by differences in expiratory flows before and after inhalation of hypertonic saline
[Time Frame: 100 minutes]
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Infant tolerance of inhalation of hypertonic saline
[Time Frame: 100 minutes]
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Secondary Outcome(s)
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The usefulness of inhalation of hypertonic saline as a technique to obtain secretions from the lower respiratory tract for microbiological diagnosis
[Time Frame: 100 minutes]
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Secondary ID(s)
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1000008380
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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