Clinical trial NCT05239559: Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia
Official title: Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure for Treatment of Bangladeshi Children With Severe Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feasibility
Keywords: Childhood
Severe Pneumonia
Hypoxaemia
bubble continuous positive airway pressure
Feasibility and acceptability
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: NIHR Global Health Research Unit on Respiratory Health (RESPIRE)
name: Director General of Health Services, Bangladesh
First posted: 2022-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2-24 months having hypoxaemia in pneumonia (Pneumonia defined by WHO criteria)

Brief 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. 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.
2. To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals.
3. 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.
4. 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:

1. To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP.
2. 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.
3. A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes.
4. 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


Eligibility criteria: INCLUSION CRITERIA

* 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.
  * 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

EXCLUSION CRITERIA

* 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

Primary outcomes:
measure: The structural, functional and operational challenges will be described
timeFrame: 44 month
measure: 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
timeFrame: 44 month
measure: A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
timeFrame: 44 month
measure: Feasibility and acceptability of introducing bubble CPAP
timeFrame: 44 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Institute of Child and Mother Health
city: Kustia
country: Bangladesh
facility: 250 bedded General hospital
Study officials:
affiliation: Senior Scientist
name: Md. Mohammod J Chisti, PhD
role: PRINCIPAL_INVESTIGATOR
References: