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

International Centre for Diarrhoeal Disease Research (icddr,b)

Status

Completed

Conditions

Severe Pneumonia

Treatments

Device: Bubble CPAP

Device: Low flow oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT03870243

PR-18052

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,240 patients

Sex

All

Ages

1 to 59 months old

Volunteers

No Healthy Volunteers

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