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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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26 September 2016 |
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Main ID: |
NCT02100865 |
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Date of registration:
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27/03/2014 |
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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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Solar Powered Oxygen Delivery
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Scientific title:
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Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02100865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Michael T Hawkes, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Name:
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Robert O Opoka, MBChB, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makerere University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age <13 years
- IMCI defined pneumonia, severe pneumonia or very severe disease
- Hypoxemia (SpO2<90%) based on non-invasive pulse oximetry
- Hospital admission warranted based on clinician judgment
- Consent to blood sampling and data collection
Exclusion Criteria:
- SpO2 =90%
- Suspected pulmonary tuberculosis
- Outpatient management
- Denial of consent to participate in study
Age minimum:
N/A
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypoxemia
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Pneumonia
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Intervention(s)
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Device: Solar powered oxygen
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Device: Oxygen from cylinders
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Primary Outcome(s)
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Length of hospital stay
[Time Frame: Until end of hospitalization (usually 3 to 7 days)]
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Secondary Outcome(s)
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Duration of supplemental oxygen therapy
[Time Frame: Until hospital discharge (usually 3 to 7 days)]
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Oxygen delivery system failure
[Time Frame: During hospitalization (usually 3 to 7 days)]
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Cost
[Time Frame: Until hospital discharge (usually 3 to 7 days)]
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Mortality
[Time Frame: At hospital discharge (usually 3 to 7 days)]
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Lambaréné Organ Dysfunction Score (LODS)
[Time Frame: Until hospital discharge (usually 3 to 7 days)]
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Proportion of patients successfully oxygenated
[Time Frame: 6 hours]
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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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