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

Severe Pneumonia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870243
• Other study ID #: PR-18052
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: July 27, 2022

Study information

• Verified date: August 2023
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1240
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Severe Pneumonia

Intervention

Device:
• Bubble CPAP
To see the effectiveness of Bubble Continuous Positive Airway Pressure (bCPAP) in children with severe pneumonia
• Low flow oxygen
To see the effectiveness of low flow oxygen in children with severe pneumonia

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)	Dhaka	Mohakhali

Sponsors (2)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Armauer Hansen Research Institute (AHRI), Ethiopia

Country where clinical trial is conducted

Bangladesh, 

References & Publications (24)

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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

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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay in days	Length of hospital stay will be measured and reported in days.	12-18 months (Mid April 2021 to Mid October 2022)
Other	Incidence of nasal trauma, gastric distention, shock and air leaks in number	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)
Other	Duration of bCPAP in hour	Duration of bCPAP will be measured and reported in hour/hours.	12-18 months (Mid April 2021 to Mid October 2022)
Other	Acceptability of bCPAP by nurses and physicians will be measured in number and reported in percentage	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)
Primary	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	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
Primary	For stage III: Primary outcome: Treatment failure	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	Secondary outcomes: • Death • Adverse events (pneumothorax, abdominal distension, nasal trauma, aspiration pneumonia ) encountered	All will be measured in number and reported in percentage.	12-18 months (Mid April 2021 to Mid October 2022)