- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05239559
Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia (Child-bCPAP)
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:
- 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Dhaka, Bangladesh, 1212
- Institute of Child and Mother Health
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Kustia, Bangladesh
- 250 Bedded General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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bubble CPAP arm
Oxygen will be delivered by Bubble CPAP device, which will have three components:
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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:
The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The structural, functional and operational challenges will be described
Prazo: 44 month
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Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
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44 month
|
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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
Prazo: 44 month
|
The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff.
Hands-on training will be done.
|
44 month
|
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A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
Prazo: 44 month
|
Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
|
44 month
|
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Feasibility and acceptability of introducing bubble CPAP
Prazo: 44 month
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Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
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44 month
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Md. Mohammod J Chisti, PhD, Senior Scientist
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PR-18049
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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