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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: |
NCT02484183 |
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Date of registration:
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23/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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CPAP Improving Mortality for Pneumonia in African Children Trial
IMPACT |
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Scientific title:
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Effectiveness of Bubble Continuous Positive Airway Pressure (CPAP) in Reducing Childhood Pneumonia Mortality in Malawi |
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Date of first enrolment:
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June 23, 2015 |
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Target sample size:
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646 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02484183 |
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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: 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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Malawi
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Contacts
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Name:
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Eric D McCollum, 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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Johns Hopkins School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meets World Health Organization (WHO) severe pneumonia criteria and is either Human
Immunodeficiency Virus (HIV)-infected, HIV-exposed, severely malnourished, or has
severe hypoxemia without HIV-infection, HIV-exposure, or severe malnutrition.
Exclusion Criteria:
- Any psychosocial condition or circumstance that, in the opinion of the investigators,
would interfere with the conduct of the study. Prior participation in the study during
a previous pneumonia diagnosis.
Age minimum:
1 Month
Age maximum:
59 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus (HIV)
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Pneumonia
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Hypoxemia
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Malnutrition
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Intervention(s)
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Device: bubble continuous positive airway pressure (CPAP)
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Primary Outcome(s)
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Pneumonia mortality
[Time Frame: Participants followed for duration of hospital stay, an expected average of 7 days]
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Secondary Outcome(s)
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Treatment failure
[Time Frame: 14 days]
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Post-discharge mortality
[Time Frame: 30 days after hospital discharge.]
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Relapse
[Time Frame: 30 days]
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Secondary ID(s)
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IRB00055734
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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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