NCT03870243

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

Completed NA Last updated 7 August 2023

What this trial tests

NA trial testing Bubble CPAP in Severe Pneumonia in 1,240 participants. Completed in 27 July 2022.

Timeline

2 September 2019

Primary endpoint
27 July 2022

27 July 2022

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,240
Start date	2 September 2019
Primary completion	27 July 2022
Estimated completion	27 July 2022
Sites	1 location across Bangladesh

Drugs / interventions tested

• Bubble CPAP
• Low flow oxygen — full drug profile →

Conditions studied

• Severe Pneumonia — all drugs for Severe Pneumonia →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 1 Month to 59 Months, any sex, with Severe Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of bubble continuous positive airway pressure for treatment of children aged 1-59 months with severe pneumonia and hypoxaemia in Ethiopia: a pragmatic cluster-randomised controlled trial.
   Gebre M, Haile K, Duke T, Faruk MT, et al · · 2024 · cited 8× · PMID 38522443 · DOI 10.1016/s2214-109x(24)00032-9
2. Effectiveness of Bubble Continuous Positive Airway Pressure (BCPAP) for Treatment of Children Aged 1-59 Months with Severe Pneumonia and Hypoxemia in Ethiopia: A <i>Pragmatic Cluster Randomized Controlled Clinical Trial</i>.
   Gebre M, Haile K, Duke T, Faruk MT, et al · · 2022 · cited 5× · PMID 36078864 · DOI 10.3390/jcm11174934