Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial

Detailed Summary

Principal Investigator: Mohammod Jobayer Chisti Research Protocol Title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) for Treatment of Children aged 1-59 months with Severe Pneumonia in Ethiopia: A Cluster Randomized Controlled Clinical Trial Proposed start date: 1st July 2018, Estimated end date: 31st December 2022 Background: Feasibility and acceptability followed by effectiveness of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale. Objectives: Stages I and II * To assess the feasibility and acceptability (not only by patients' care-givers but also by physicians and nurses) of bubble CPAP in treating childhood severe pneumonia in two tertiary hospitals in Stage I and in two district hospitals in Stage II * To record adverse events following use of bubble CPAP in these settings * To understand how much resource and time are needed to institutionalize and maintain bubble CPAP as a routine practice in the health system Stage III: * To determine therapeutic efficacy/effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure in children admitted to hospitals with severe pneumonia and hypoxemia * To determine therapeutic effectiveness of bubble CPAP compared to WHO standard low flow oxygen in reducing treatment failure \& mortality in children aged 1-12 months admitted to hospitals with severe pneumonia and hypoxemia * To record adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia) encountered.

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