Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia
NCT ID: NCT03870243
Last Updated: 2023-08-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1240 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-02
Study Completion Date
2022-07-27
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Severe Pneumonia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Children aged 1-59 months with Severe Pneumonia in Ethiopia, divided in two arms; one arm will get bCPAP other arm will get WHO recommended low flow oxygen.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
As it was an open-labeled randomized controlled clinical trial, there was no masking in any intervention.
Study Groups
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Bubble CPAP
6 hospitals will be selected randomly for this arm
Group Type
ACTIVE_COMPARATOR
Bubble CPAP
Intervention Type
DEVICE
To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia
Low flow oxygen
6 hospitals will be selected for low flow oxygen therapy
Group Type
ACTIVE_COMPARATOR
Low flow oxygen
Intervention Type
DEVICE
To see the effectiveness of low flow oxygen in children with severe pneumonia
Interventions
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Bubble CPAP
To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia
Intervention Type
DEVICE
Low flow oxygen
To see the effectiveness of low flow oxygen in children with severe pneumonia
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* Tracheostomy
* Pneumothorax
* Needs mechanical ventilation for any specific reason as decided by the clinician
Minimum Eligible Age
1 Month
Maximum Eligible Age
59 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Armauer Hansen Research Institute (AHRI), Ethiopia
UNKNOWN
Sponsor Role
collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mohammod Jobayer Chisti, PhD
Role: PRINCIPAL_INVESTIGATOR
International Centre for Diarrhoeal Disease Research, Bangladesh
Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Mohakhali, Bangladesh
Site Status
Countries
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Bangladesh
References
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UNICEF. Committing to Child Survival: A Promise Renewed. Progress Report 2015 2015
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
Chisti MJ, Salam MA, Smith JH, Ahmed T, Pietroni MA, Shahunja KM, Shahid AS, Faruque AS, Ashraf H, Bardhan PK, Sharifuzzaman, Graham SM, Duke T. Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1057-65. doi: 10.1016/S0140-6736(15)60249-5. Epub 2015 Aug 19.
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BACKGROUND
Chisti MJ, Duke T, Ahmed T, Shahunja KM, Shahid ASMSB, G. FAS, et al. The Use of Bubble CPAP and Humidified High Flow Nasal Cannula Oxygen Therapy in Children with Severe Pneumonia and Hypoxemia: A Systematic Review of the Evidence. Bangladesh Crit Care J. 2014; 2:71-8
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BACKGROUND
Liptsen E, Aghai ZH, Pyon KH, Saslow JG, Nakhla T, Long J, Steele AM, Habib RH, Courtney SE. Work of breathing during nasal continuous positive airway pressure in preterm infants: a comparison of bubble vs variable-flow devices. J Perinatol. 2005 Jul;25(7):453-8. doi: 10.1038/sj.jp.7211325.
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van den Heuvel M, Blencowe H, Mittermayer K, Rylance S, Couperus A, Heikens GT, Bandsma RH. Introduction of bubble CPAP in a teaching hospital in Malawi. Ann Trop Paediatr. 2011;31(1):59-65. doi: 10.1179/1465328110Y.0000000001.
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Daga S, Mhatre S, Borhade A, Khan D. Home-made continuous positive airways pressure device may reduce mortality in neonates with respiratory distress in low-resource setting. J Trop Pediatr. 2014 Oct;60(5):343-7. doi: 10.1093/tropej/fmu023. Epub 2014 Apr 23.
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Koyamaibole L, Kado J, Qovu JD, Colquhoun S, Duke T. An evaluation of bubble-CPAP in a neonatal unit in a developing country: effective respiratory support that can be applied by nurses. J Trop Pediatr. 2006 Aug;52(4):249-53. doi: 10.1093/tropej/fmi109. Epub 2005 Dec 2.
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BACKGROUND
Federal Democratic Republic of Ethiopia Ministry of Health. Integrated Management of Newborn and Childhood Illness, Part 1 Blended Learning Module for the Health Extension Programme
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Reference Type
DERIVED
Other Identifiers
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PR-18052
Identifier Type: -
Identifier Source: org_study_id
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