Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia

Methodology:

Cluster randomized controlled clinical trial

Methodology:

• Stages I and II: Feasibility/demonstration stage will be done as an internal pilot in 3 hospitals

a. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP

• Stage III: Implementation of bubble CPAP will be done in 12 hospitals a. It will be done following a cluster randomized design

Data collection-socio-demographic and clinical data will be collected using structured questionnaire by trained nurses and physicians.

Research Site:

St. Paulos Millennium Medical College, Yekatit 12 and Tikur Anbessa Specialized hospitals, 14 district hospitals

Number of Participants/Patients:

Stage I-30 children in each tertiary hospital (this stage has completed and we enrolled 49 children from two tertiary hospitals; these 49 enrolled children took double of our anticipated time {4 months}) Stage II- 20 children in each general hospital (2 general/district hospitals, we have enrolled total 40 children from this two hospitals from January 2020 to July 2020, which included COVID-19 period) Stage III-1240 children in 12 general/district hospitals (620 in bubble CPAP arm and 620 in WHO standard low flow arm; each hospital will be the cluster and 6 will be randomized to each arm)

Main Inclusion Criteria:

• Age between 1 month and 59 months
• Meet WHO clinical criteria for severe pneumonia with hypoxemia
• Hypoxemia (Oxygen saturation <90% in room air)
• Parent/guardian gives informed consent to participate in the study

Statistical Analysis:

• STATA -14: for initial two phases descriptive analysis of level of feasibility and acceptability will be performed
• For the phase III: We shall follow the principle of intention to treat. --Treatment failure and/or death will be analyzed using χ² or Fisher's exact tests as appropriate.
• Primary and secondary outcomes will be compared by calculating relative risks (RRs) and their 95% confidence intervals.
• Log-linear binomial regression will be applied to adjust for covariates to evaluate the true impact of bubble CPAP in evaluating primary and secondary outcomes and to adjust for baseline differences.
• Continuous variables will be analyzed using the Student t-test or the Mann-Whitney test as appropriate.

Study Duration:

48 months.

Inclusion criteria

• Age between 1 month and 59 months,
• Meet WHO clinical criteria for severe pneumonia with hypoxemia.
• Oxygen saturation <90% despite standard flow oxygen therapy
• Parent/guardian gives informed consent to participate in the study

Exclusion criteria

• Known congenital heart disease, asthma, or upper -airway obstruction
• Tracheostomy
• Pneumothorax
• Needs mechanical ventilation for any specific reason as decided by the clinician