feasibility and acceptability followed by effectiveness of bcpap for treatment of children aged 1-59 months with severe pneumonia in ethiopia

Conditions: Severe Pneumonia

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.

methodology: cluster randomized controlled clinical trial methodology: 1. 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 2. 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.

Eligibility criteria:
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

Keywords: bubble cpap young children severe pneumonia hypoxemia treatment failure mortality