- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Dhaka, 방글라데시, 1212
- Institute of Child and Mother Health
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Kustia, 방글라데시
- 250 Bedded General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The structural, functional and operational challenges will be described
기간: 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
기간: 44 month
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The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff.
Hands-on training will be done.
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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
기간: 44 month
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Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
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44 month
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Feasibility and acceptability of introducing bubble CPAP
기간: 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
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Md. Mohammod J Chisti, PhD, Senior Scientist
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PR-18049
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Bubble CPAP oxygen delivery device에 대한 임상 시험
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RxSight, Inc.완전한
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RxSight, Inc.완전한
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RxSight, Inc.완전한
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TriHealth Inc.아직 모집하지 않음통증 | 과민성 방광 | 방광, 과잉활동 | 요실금 | 골반저 장애 | 방광, 신경인성 | 급박성 요실금 | 요실금, 절박 | 신경성 방광 | 방광 신경 재생미국