Status:
COMPLETED
Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Armauer Hansen Research Institute (AHRI), Ethiopia
Conditions:
Severe Pneumonia
Eligibility:
All Genders
1-59 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- Known congenital heart disease, asthma, or upper -airway obstruction
- Tracheostomy
- Pneumothorax
- Needs mechanical ventilation for any specific reason as decided by the clinician
Key Trial Info
Start Date :
September 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
1240 Patients enrolled
Trial Details
Trial ID
NCT03870243
Start Date
September 2 2019
End Date
July 27 2022
Last Update
August 7 2023
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Mohakhali, Bangladesh, 1212