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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 4
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Recruiting
Dhaka
Contact Information
Primary
Mohammod Jobayer Chisti, PhD
chisti@icddrb.org
+88-29827084
Backup
Meseret Gebre Behute, MD
mesibire@yahoo.com
251 911977885
Time Frame
Start Date: September 2, 2019
Estimated Completion Date: December 31, 2022
Participants
Target number of participants: 1240
Treatments
Active Comparator: Bubble CPAP
6 hospitals will be selected randomly for this arm
Active Comparator: Low flow oxygen
6 hospitals will be selected for low flow oxygen therapy
Related Therapeutic Areas
Sponsors
Collaborators: Armauer Hansen Research Institute (AHRI), Ethiopia
Leads: International Centre for Diarrhoeal Disease Research, Bangladesh

This content was sourced from clinicaltrials.gov

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