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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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16 December 2017 |
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Main ID: |
NCT03143231 |
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Date of registration:
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21/04/2017 |
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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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Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis
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Scientific title:
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Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis |
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Date of first enrolment:
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March 1, 2016 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03143231 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Mariam Rajab, 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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Makassed General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants up to 24 months of age with diagnosis of acute bronchiolitis
- In accordance with 2006 American Academy of Pediatrics (AAP) definition of
bronchiolitis,we did not limit to the first episode of wheeze
- Patients with the diagnosis of bronchiolitis
Exclusion Criteria:
- Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic
lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen)
- Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular
disease
Age minimum:
N/A
Age maximum:
2 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Length of Hospital Stay
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Intervention(s)
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Other: Normal saline
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Other: Hypertonic saline
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Primary Outcome(s)
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Length of stay
[Time Frame: an average of 5 days]
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Secondary Outcome(s)
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use of mechanical ventilator
[Time Frame: an average of 3 days]
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transfer to pediatric intensive care unit (PICU)
[Time Frame: an average of 3 days]
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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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