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

NCT03870243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1240

Last updated 2023-08-07

No results posted yet for this study

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.

Conditions

  • Severe Pneumonia

Interventions

DEVICE

Bubble CPAP

To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia

DEVICE

Low flow oxygen

To see the effectiveness of low flow oxygen in children with severe pneumonia

Sponsors & Collaborators

  • Armauer Hansen Research Institute (AHRI), Ethiopia

    collaborator UNKNOWN

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Mohammod Jobayer Chisti, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2022-07-27
Completion
2022-07-27

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870243 on ClinicalTrials.gov