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

August 3, 2023 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP

  2. 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.

Study Type

Interventional

Enrollment (Actual)

1240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Mohakhali
      • Dhaka, Mohakhali, Bangladesh, 1212
        • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bubble CPAP
6 hospitals will be selected randomly for this arm
Device: Bubble CPAP
To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia
Active Comparator: Low flow oxygen
6 hospitals will be selected for low flow oxygen therapy
Device: Low flow oxygen
To see the effectiveness of low flow oxygen in children with severe pneumonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For stage I and II feasibility and acceptability of bubble CPAP in two tertiary and two district hospitals will be measured in number and reported in percentage
Time Frame: 7 months
Patient level and health professional level challenge is the outcome of phase I and II. All will be measured in number and reported in percentage. For stage I and II: Primary outcome: operational challenges that may include availability of pulse oxymetry, IV cannula, IV antibiotics, oxygen supply system and nasal catheters for treating severe pneumonia Secondary outcomes: prevalence of severe pneumonia associated hypoxemia, their treatment practices, adverse events, mortality and treatment failure
7 months
For stage III: Primary outcome: Treatment failure
Time Frame: 12-18 months (Mid April 2021 to Mid October 2022)

According to this protocol treatment failure will be declared if the following criteria are met:

A. Presence of severe hypoxemia (SpO2<85%) at any time after at least one hour of intervention plus severe respiratory distress when the child is receiving BCPAP/LF OR, B. If the patient developed the indication of mechanical ventilation when the child is receiving BCPAP/LF OR, C. If the patient died during hospitalization OR, D. If the patient left against medical advice (LAMA) due to lack of improvement or deterioration of the child during hospitalization

All will be measured in number and reported in percentage.
12-18 months (Mid April 2021 to Mid October 2022)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered
Time Frame: 12-18 months (Mid April 2021 to Mid October 2022)
All will be measured in number and reported in percentage.
12-18 months (Mid April 2021 to Mid October 2022)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay in days
Time Frame: 12-18 months (Mid April 2021 to Mid October 2022)
Length of hospital stay will be measured and reported in days.
12-18 months (Mid April 2021 to Mid October 2022)
Incidence of nasal trauma, gastric distention, shock and air leaks in number
Time Frame: 12-18 months (Mid April 2021 to Mid October 2022)
Incidence of nasal trauma, gastric distention, shock and air leaks will be measured in number and reported in percentage.
12-18 months (Mid April 2021 to Mid October 2022)
Duration of bCPAP in hour
Time Frame: 12-18 months (Mid April 2021 to Mid October 2022)
Duration of bCPAP will be measured and reported in hour/hours.
12-18 months (Mid April 2021 to Mid October 2022)
Acceptability of bCPAP by nurses and physicians will be measured in number and reported in percentage
Time Frame: 12-18 months (Mid April 2021 to Mid October 2022)
Acceptability of bCPAP by nurses and physicians will be measured in number and reported in percentage.
12-18 months (Mid April 2021 to Mid October 2022)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

Armauer Hansen Research Institute (AHRI), Ethiopia

Investigators

  • Principal Investigator: Mohammod Jobayer Chisti, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

July 27, 2022

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-18052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share the final outcome after completing the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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