Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia
Condition: Severe Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Bubble CPAP; Low flow oxygen
Intervention type(s): Device; Device
Intervention description(s): To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia; To see the effectiveness of low flow oxygen in children with severe pneumonia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children aged 1-59 months with Severe Pneumonia in Ethiopia, divided in two arms; one arm will get bCPAP other arm will get WHO recommended low flow oxygen.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bubble CPAP; Young Children; Severe Pneumonia; Hypoxemia; Treatment failure; Mortality