FeasibilityChild-bCPAPNCT05239559
Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia
An observational study of Feasibility, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
Trial summary
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale. Objective: 1. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Feasibility
- What is being tested?
- Bubble CPAP oxygen delivery device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesBangladesh
- Study dates
- 1 Dec 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2-24 months having hypoxaemia in pneumonia (Pneumonia defined by WHO criteria)
Who may be able to join
- Staff:
- Staff (medical and nursing) employed at the two selected hospitals with duties that include care of children with pneumonia
- Staff who agree to participate and give written informed consent
- Children for assessment of hypoxaemia in pneumonia and outcomes:
- Age between 2 - 24 months
- Attend one of the two study hospitals for the assessment of pneumonia by hospital clinician.
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- Pneumonia defined by WHO criteria
- Children receiving bubble CPAP:
- Age between 2 - 24 months.
- Diagnosis of pneumonia by a hospital clinician together with hypoxaemia (SpO2<90%).
- Parent/guardian gives informed consent to participate in the study
Who cannot join
- Hospital staff:
- o There will be no exclusion criteria
- Children for assessment of hypoxaemia in pneumonia and outcomes, and children receiving bubble CPAP:
- Known congenital heart disease, asthma, pulmonary TB and other chronic respiratory disorders
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Institute of Child and Mother Health
Dhaka, 1212
250 bedded General hospital
Kustia
About this study
Official title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure for Treatment of Bangladeshi Children With Severe Pneumonia
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objective:
Read more
- To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial.
- To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals.
- To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia.
- To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals.
Methodology:
Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP.
Outcome:
- To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP.
- To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh.
- A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes.
- A qualitative assessment of the feasibility of introducing bubble CPAP.
Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital)
Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study.
Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed.
Study duration: 44 months
- Conditions
- Feasibility
- Being tested
- Bubble CPAP oxygen delivery device
- Keywords
- Childhood, Severe Pneumonia, Hypoxaemia, bubble continuous positive airway pressure, Feasibility and acceptability
- Medical subject headings
- Pneumonia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble CPAP oxygen delivery deviceDevice
In Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the nasopharynx of the baby. An underwater tube (expiratory arm) that acts as a blow off valve is interposed between the oxygen source and the baby. Adjusting the height of the water column above the exit of the tube can regulate the pressure in the system and the amount of CPAP delivered to the baby. The constant bubbling of gas through the blow off mechanism delivers the bubbling CPAP effect. Oxygen may be delivered by nasal prongs inserted into the nostril of child.
The system has three components:
- Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min.
- A nasal interface connecting the child's airway with the circuit:
- An expiratory arm with the distal end submerged in water to generate end-expiratory pressure.
The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines.
| Study group | Role | What they receive |
|---|---|---|
| bubble CPAP arm | Oxygen will be delivered by Bubble CPAP device, which will have three components:
1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min.
2. A nasal interface connecting the child's airway with the circuit: short nasal prongs are generally used to deliver nasal CPAP. They must be carefully fitted to minimize leakage of air (otherwise, CPAP will not be achieved) .
3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure: in bubble CPAP, the positive pressure is maintained by placing the far end of the expiratory tubing in water. The pressure is adjusted by altering the depth of the tube under the surface of the water. Receives: Device: Bubble CPAP oxygen delivery device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The structural, functional and operational challenges will be described
Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
Measured: 44 month
To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh
The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.
Measured: 44 month
A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
Measured: 44 month
Feasibility and acceptability of introducing bubble CPAP
Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
Measured: 44 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Dec 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeasibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Directorate General of Health Services, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Md. Mohammod J Chisti, PhD, Principal investigator, Senior Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239559
- Sponsor's protocol ID
- PR-18049
- Acronym
- Child-bCPAP
- Status last verified
- Dec 2021
- First submitted
- 16 Oct 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the end of the study, data will be analyzed as ter the defined data analysis plan on the protocol. Study results will be shared with other researchers by journal publications, conferences proceedings and dissemination programs
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure for Treatment of Bangladeshi Children With Severe Pneumonia
- ClinicalTrials.gov ID
- NCT05239559
- Acronym / sponsor ID
- Child-bCPAP / PR-18049
- Conditions
- Feasibility
- Keywords
- Childhood, Severe Pneumonia, Hypoxaemia, bubble continuous positive airway pressure, Feasibility and acceptability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of Edinburgh, NIHR Global Health Research Unit on Respiratory Health (RESPIRE), Directorate General of Health Services, Bangladesh
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objective:
- To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial.
- To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals.
- To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia.
- To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals.
Methodology:
Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP.
Outcome:
- To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP.
- To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh.
- A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes.
- A qualitative assessment of the feasibility of introducing bubble CPAP.
Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital)
Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study.
Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed.
Study duration: 44 months
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bubble CPAP arm | – | Device: Bubble CPAP oxygen delivery deviceOxygen will be delivered by Bubble CPAP device, which will have three components: 1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min. 2. A nasal interface connecting the child's airway with the circuit: short nasal prongs are generally used to deliver nasal CPAP. They must be carefully fitted to minimize leakage of air (otherwise, CPAP will not be achieved) . 3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure: in bubble CPAP, the positive pressure is maintained by placing the far end of the expiratory tubing in water. The pressure is adjusted by altering the depth of the tube under the surface of the water. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2-24 months having hypoxaemia in pneumonia (Pneumonia defined by WHO criteria)
Key inclusion criteria (11 listed)
- Staff:
- Children for assessment of hypoxaemia in pneumonia and outcomes:
- Children receiving bubble CPAP:
Key exclusion criteria (4 listed)
- Hospital staff:
- o There will be no exclusion criteria
- Children for assessment of hypoxaemia in pneumonia and outcomes, and children receiving bubble CPAP:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bubble CPAP oxygen delivery deviceIn Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the nasopharynx of the baby. An underwater tube (expiratory arm) that acts as a blow off valve is interposed between the oxygen source and the baby. Adjusting the height of the water column above the exit of the tube can regulate the pressure in the system and the amount of CPAP delivered to the baby. The constant bubbling of gas through the blow off mechanism delivers the bubbling CPAP effect. Oxygen may be delivered by nasal prongs inserted into the nostril of child. The system has three components: 1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min. 2. A nasal interface connecting the child's airway with the circuit: 3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure. The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines. | Device | bubble CPAP arm |
Primary outcome
The structural, functional and operational challenges will be described
Time frame: 44 month
Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh
Time frame: 44 month
The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.
A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
Time frame: 44 month
Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
Feasibility and acceptability of introducing bubble CPAP
Time frame: 44 month
Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No. After the end of the study, data will be analyzed as ter the defined data analysis plan on the protocol. Study results will be shared with other researchers by journal publications, conferences proceedings and dissemination programs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Md. Mohammod J Chisti, PhD principal investigator
Senior Scientist
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feasibility, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The structural, functional and operational challenges will be described (time frame: 44 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.