跳至主要内容
临床试验/CTRI/2024/02/063010
CTRI/2024/02/063010尚未招募Phase 3 4

Low-Cost Bubble Continuous Positive Airway Pressure (CPAP) In Indian Tertiary PICU -A Mixed Method Feasibility Study.

Mysore Medical College and Research Institute Mysore1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Mortality/ Death

研究概览

简要总结

Pneumonia is a leading infectious cause of death globally among children younger than five years. Accounting for one third of all under five deaths from infection. More than 99% of pneumonia deaths are in low and middle income countries and closely linked to poverty. It is one of the most important causes of under five deaths in India . More than 1.1 million, under five years of age children die from pneumonia every year accounting for almost 17% under five deaths worldwide . In India during the year 2013 about 31.7 million cases of acute respiratory infections were reported during 2013 about 3278 people died of ARI and 2597 died of pneumonia  Pneumonia was responsible for about 18% of all under five year deaths in India interventions that affect mortality due to pneumonia are thus of greater importance. In any effort to improve childhood survival.

The annual global incidence of pneumonia is 9 to 0000 new cases per year out of which 282000 occurring in South Asia , though, there is evidence of decreased mortality and decreased need for invasive ventilation after use of CPAP in managing units with respiratory distress, secondary to RDS , MAS and apnoea of prematurity in NICU. There is only limited evidence for use of CPAP in infants and children with respiratory conditions like pneumonia, ARDS, pulmonary edema and status asthmaticus with very few observational and randomised control studies, indicating that CPAP exhibits promising potential in enhancing ventilation and oxygenation among infants, with pneumonia with respiratory distress and use of CPAP, may mitigate the need for endotracheal, intubation and potentially need to shorter duration of PICU stays for the young patients . Among different CPAP devices, bubble CPAP demonstrate the specific advantage of cost effectiveness, ease of assembling and its operability with any available oxygen source gives it an upper hand in low and middle income countries. Nevertheless, there is minimal evidence of CPAP efficacy in pneumonia. This study aims to investigate low-cost bubble CPAP, safety and effectiveness in paediatric respiratory distress. As a result of pneumonia, filling a critical knowledge gap in paediatric respiratory care to minimise mortality and morbidity .

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 36.00 Month(s)(—)
性别
All

入选标准

  • All children with lower respiratory tract infection admitted to Paediatric Intensive Care unit needing bubble CPAP as respiratory support will be included for the study.

排除标准

  • Children admitted to Paediatric Intensive Care unit.
  • needing CPAP as respiratory support with diagnosis other than lower respiratory tract infection will be excluded from the study.

结局指标

主要结局

Mortality/ Death

时间窗: During PICU stay on CPAP

次要结局

  • Duration of CPAP use(during PICU stay)
  • Intubation(During PICU stay)
  • Nasal injury - skin erosion , ulceration, bleeding, septal, injury, or scaring(During PICU stay)
  • Airleak syndromes(pneumothorax ,pneumomediastinum, & pneumopericardium)
  • Duration of hospital stay(At discharge)
  • Nasopharyngeal swab culture(During PICU stay)

研究者

发起方
Mysore Medical College and Research Institute Mysore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr M R Savitha

Mysore Medical College and Research Institute, Mysore

研究点 (1)

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