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

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh (Other)

Overall Status

Recruiting

CT.gov ID

NCT03870243

Collaborator

Armauer Hansen Research Institute (AHRI), Ethiopia (Other)

1,240

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Severe Pneumonia	Device: Bubble CPAP Device: Low flow oxygen	N/A

Detailed Description

Methodology:

Cluster randomized controlled clinical trial

Methodology:

Stages I and II: Feasibility/demonstration stage will be done as an internal pilot in 3 hospitals

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

In stage III among 12 district hospitals, 6 hospitals will randomly selected for bubble CPAP and another 6 hospitals will get low flow oxygen therapy. Masking of the personnel who are related to the study will be maintained from beginning.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 2, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 [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
For stage III: Primary outcome: Treatment failure [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.

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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