Clinical trial NCT03870243: Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Pneumonia
Keywords: Bubble CPAP
Young Children
Severe Pneumonia
Hypoxemia
Treatment failure
Mortality
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Armauer Hansen Research Institute (AHRI), Ethiopia
First posted: 2019-03-12
Enrollment: 1240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage
timeFrame: 7 months
measure: For stage III: Primary outcome: Treatment failure
timeFrame: 12-18 months (Mid April 2021 to Mid October 2022)
Secondary outcomes:
measure: Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered
timeFrame: 12-18 months (Mid April 2021 to Mid October 2022)
Other outcomes:
measure: Length of hospital stay in days
timeFrame: 12-18 months (Mid April 2021 to Mid October 2022)
measure: Incidence of nasal trauma, gastric distention, shock and air leaks in number
timeFrame: 12-18 months (Mid April 2021 to Mid October 2022)
measure: Duration of bCPAP in hour
timeFrame: 12-18 months (Mid April 2021 to Mid October 2022)
measure: Acceptability of bCPAP by nurses and physicians will be measured in number and reported in percentage
timeFrame: 12-18 months (Mid April 2021 to Mid October 2022)
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
state: Mohakhali
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mohammod Jobayer Chisti, PhD
role: PRINCIPAL_INVESTIGATOR
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